Data / Medical devices / United States / Theken Companies, LLC
Theken Companies, LLC: FDA-registered device maker in Akron, OH, United States, 7 510(k) clearances
Theken Companies, LLC is registered with the FDA (registration 3002498892) in Akron, OH, United States. It lists 25 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 13, 2024. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002498892
- Address
- 1800 Triplett Blvd, Akron, OH, United States, 44306
- Owner or operator
- Theken Companies, LLC (10050903)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 9, 2016
- Registered through
- 2027
- Brand names listed
- BONE HOOK, BROACH, DEPTH GAUGE, DRILL, DRILL GUIDE, EXTRACTOR, FORCEPS, HAMMER 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 |
|---|---|---|---|---|---|---|
| September 13, 2024 | K241875 | TheRay Collared and Collarless Femoral Stem | MEH | Substantially Equivalent | Nextstep Arthropedix | accessdata.fda.gov |
| September 30, 2022 | K220336 | Mg-PSZ Ceramic Femoral Head | LPH | Substantially Equivalent | Theken Companies | accessdata.fda.gov |
| September 17, 2019 | K191297 | iNSitu Bipolar Hip System | KWY | Substantially Equivalent | Theken Companies, LLC | accessdata.fda.gov |
| August 30, 2019 | K192071 | iNSitu Total Hip System | LPH | Substantially Equivalent | Theken Companies, LLC | accessdata.fda.gov |
| August 20, 2019 | K191936 | iNSitu Total Hip System | LPH | Substantially Equivalent | Thecken Companies, LLC | accessdata.fda.gov |
| September 21, 2017 | K172501 | iNSitu Total Hip System | LPH | Substantially Equivalent | Theken Companies, LLC | accessdata.fda.gov |
| October 14, 2016 | K161184 | iNSitu Total Hip System | LPH | Substantially Equivalent | Theken Companies, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2025 | 97676 | Class II | Ongoing | iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar H | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. | accessdata.fda.gov |
| August 26, 2010 | 56858 | Not yet classified | Terminated | Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affec | The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes. | accessdata.fda.gov |
| July 29, 2010 | 56502 | Not yet classified | Terminated | Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The l | The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures. | accessdata.fda.gov |
| August 27, 2008 | 49544 | Not yet classified | Terminated | Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe. | The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010. | accessdata.fda.gov |
| August 26, 2008 | 52798 | Not yet classified | Terminated | iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. | Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04. | accessdata.fda.gov |
| July 11, 2008 | 49018 | Not yet classified | Terminated | FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosp | The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06. | accessdata.fda.gov |
| October 4, 2005 | 33713 | Not yet classified | Terminated | Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). | The torque value of the device may increase over time. The increase could exceed the tolerance specification. | accessdata.fda.gov |
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Updated October 21, 2025. 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.