Data / Medical devices / United Kingdom / Depuy CMW
Depuy CMW: FDA-registered device maker in Blackpool, Lancashire, United Kingdom, 27 510(k) clearances and 1 PMA approval
Depuy CMW is registered with the FDA (registration 9610921) in Blackpool, Lancashire, United Kingdom. It lists 18 device types. The FDA files 27 510(k) clearances and 1 PMA approval under its listings, the newest dated May 15, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610921
- FEI number
- 3002806724
- Address
- Cornford RD., Blackpool, Lancashire, United Kingdom, FY4 4QQ
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 27, 1978
- Registered through
- 2027
- Brand names listed
- Aneuroplastic, Bone Cement, CEMENT, CEMENT MONOMER (MULTIPLE BRANDS), Cemvac, Conduit TCP Granules, Confidence High Viscosity Spinal Cement, DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) 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 |
|---|---|---|---|---|---|---|
| May 15, 2026 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | KWL | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 27, 2015 | K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | HBW | Substantially Equivalent | Depuy Synthes Companies of Johnson & Johnson | accessdata.fda.gov |
| December 22, 2011 | K112907 | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G | NDN | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| July 15, 2008 | K073115 | ORTHOMESH | HRS | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| May 14, 2008 | K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081155 | SMARTSET MV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 21, 2007 | K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | NDN | Substantially Equivalent | Depuy Spine, A Johnson & Johnson Company | accessdata.fda.gov |
| July 26, 2007 | K071776 | ANEUROPLASTIC, MODEL 43-1290 | JXH | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| February 27, 2007 | K062789 | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM | JEY | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| June 8, 2006 | K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 23, 2006 | K053022 | SYNTHES (USA) CHRONOS-BETA-TCP | LYC | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| January 6, 2006 | K053445 | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 22, 2005 | K053003 | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 22, 2005 | K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 15, 2005 | K043406 | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | NDN | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| October 22, 2004 | K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | KIH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 8, 2004 | K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | GXR | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| July 8, 2004 | K041350 | SYNTHES (USA) CHRONOS | GXP | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| July 1, 2004 | K041656 | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033382 | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 29, 2003 | K023103 | DEPUY 1 GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 8, 2003 | K030069 | SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM | JEY | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| February 13, 2003 | K023012 | SMARTSET HV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 24, 2002 | K021499 | CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 8, 2002 | K014053 | CONDUIT TCP GRANULES | MQV | Substantially Equivalent | Depuyacromed | accessdata.fda.gov |
| October 26, 1987 | K873688 | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL | JXH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 1997 | P960001 | DEPUY 1 BONE CEMENT | LOD | 8 | September 20, 1999 | accessdata.fda.gov |
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Updated May 15, 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.