Data / Medical devices / United States / Shalby Advanced Technologies, Inc.
Shalby Advanced Technologies, Inc.: FDA-registered device maker in El Dorado Hills, CA, United States, 58 510(k) clearances
Shalby Advanced Technologies, Inc. is registered with the FDA (registration 3020155054) in El Dorado Hills, CA, United States. It lists 45 device types. The FDA files 58 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020155054
- Address
- 1115 Windfield Way, El Dorado Hills, CA, United States, 95762
- Owner or operator
- Shalby Advanced Technologies, Inc. (10082275)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- July 7, 2021
- Registered through
- 2026
- Brand names listed
- Ambition Knee, Bone Chisel, Bone File, Consensus Knee System VitalitE Tibial Insert and Patellar Components, DC-POWERED ORTHOPEDIC INSTRUMENT ACCESSORY/ATTACHMENT, Driver, Prosthesis, Duraniom, Optimotion Implants Porous Metal-Backed Patella and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | HSX | Substantially Equivalent | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | accessdata.fda.gov |
| January 14, 2025 | K241180 | Consensus Knee System with TiNbN | JWH | Substantially Equivalent | Shalby Advanced Technologies | accessdata.fda.gov |
| October 5, 2017 | K170344 | Tahoe Uni Knee System | HSX | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| December 19, 2016 | K160515 | PS2 Knee System | JWH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143725 | Consensus Knee System Modular Tibial Baseplate | JWH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| July 14, 2014 | K133919 | CONSENSUS VITALITE TIBIAL INSERT | JWH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| May 19, 2014 | K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| December 17, 2013 | K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | OQG | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| November 5, 2012 | K122512 | CS2 HIP SYSTEM | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| November 5, 2012 | K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT | KWY | Substantially Equivalent | Tgm Medical, Inc. | accessdata.fda.gov |
| October 24, 2012 | K121636 | ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT | LPH | Substantially Equivalent | Tgm Medical, Inc. | accessdata.fda.gov |
| October 12, 2012 | K120595 | UNISYN PLUS HIP STEM | LWJ | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| September 10, 2012 | K121935 | TAPERSET HIP SMALL STEMS | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| May 22, 2012 | K121263 | TAPER SET HIP SYSTEM RDP STEM | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| November 4, 2011 | K112285 | MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... | JWH | Substantially Equivalent | Tgm Medical, Inc. | accessdata.fda.gov |
| September 6, 2011 | K111472 | HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON | LPH | Substantially Equivalent | Tgm Medical | accessdata.fda.gov |
| June 27, 2011 | K110950 | CONSENSUS KNEE SYSTEM | MBH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| April 1, 2011 | K110542 | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| January 26, 2011 | K102927 | CONSENSUS KNEE SYSTEM | MBH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| December 2, 2010 | K102399 | CONSENSUS TAPERSET HIP SYSTEM | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| October 6, 2010 | K100933 | CONSENSUS CS2 PLUS ACETABULAR INSERT | LPH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| June 24, 2010 | K100542 | CONSENSUS REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Consensus Orthopedics, Inc. | accessdata.fda.gov |
| November 13, 2009 | K093089 | MAGNUM NAIL | HSB | Substantially Equivalent | Robert Reid, Inc. | accessdata.fda.gov |
| January 31, 2007 | K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | LWJ | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| December 21, 2006 | K062383 | UNISYN HA PLASMA MODULAR HIP | LWJ | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| April 28, 2006 | K060635 | CONSENSUS ACETABULAR SHELL SYSTEM | LPH | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| April 10, 2003 | K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | LZO | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| April 1, 2003 | K030205 | CONSENSUS UNIPOLAR HEAD, COCR | KWL | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| July 24, 2002 | K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE | LPH | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| April 15, 2002 | K020153 | CONSENSUS ACETABLAR SHELL, TI COATED | LPH | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| February 23, 2001 | K003649 | TRITON HIP SYSTEM | LWJ | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| August 7, 2000 | K001456 | CONSENSUS KNEE SYSTEM | JWH | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| November 25, 1998 | K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI | JWH | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| January 27, 1997 | K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT | LZO | Substantially Equivalent | Hayes Medical, Inc. | accessdata.fda.gov |
| August 15, 1996 | K962215 | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| May 22, 1996 | K954818 | CONSENSUS POSTERIOR STABILIZED KNEE | JWH | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| April 26, 1996 | K953443 | CONSENSUS PCL SUBSITUTING TIBIAL INSERT | JWH | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| April 1, 1996 | K960302 | CONSENSUS ACETABULAR SHELL, ALL UHMWPE | JDI | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| April 1, 1996 | K952943 | CONSENSUS ALL POLY TIBIA | JWH | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| March 15, 1996 | K960340 | CONSENSUS APEX DOME HOLE PLUG | JDI | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| February 21, 1996 | K960339 | CONSENSUS 22MM COCRMO FEMORAL HEAD | JDI | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| February 21, 1996 | K960156 | CONSENSUS 32MM COCRMO FEMORAL HEAD | JDI | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| February 21, 1996 | K960151 | CONSENSUS 26MM COCRMO FEMORAL HEAD | JDI | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| February 20, 1996 | K955386 | CONSENSUS ZIRCONIA FEMORAL HEAD | LZO | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| November 6, 1995 | K953792 | CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 | LZO | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| May 31, 1995 | K945589 | CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE | JWH | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| May 5, 1995 | K950013 | CONSENSUS(TM) ORTHOPEDIC DRILL BIT | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| April 5, 1995 | K946197 | CONSENSUS(TM) PATELLA REAMER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| February 1, 1995 | K944946 | CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| January 27, 1995 | K945208 | CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| January 27, 1995 | K945189 | CONSENSUS HIP SYSTEM -- CALCAR PLANER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| January 27, 1995 | K945186 | CONSENUS HIP SYSTEM -- ACETABULAR REAMER | HWE | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| September 27, 1994 | K932837 | CONSENSUS KNEE SYSTEM - PRIMARY KNEE | JWH | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| August 18, 1994 | K935193 | CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM | LZO | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| July 13, 1994 | K935453 | CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM | MEH | Substantially Equivalent for Some Indications | U.S. Medical Products, Inc. | accessdata.fda.gov |
| May 18, 1994 | K933499 | CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM | LZO | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| July 21, 1993 | K922561 | CONSENSUS(TM) TOTAL HIP SYSTEM | JDL | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
| September 11, 1992 | K922560 | CONSENSUS(TM) BIPOLAR SYSTEM | KWY | Substantially Equivalent | U.S. Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.