# Tgm Medical, Inc.

- Location (FDA's records): El Dorado Hills, CA
- FDA decisions: 6 (2011–2015): 6 510(k) clearances
- Names in FDA's records: Tgm Medical, Inc. (5); Tgm Medical (1)
- Product codes: JWH (2), LPH (2), LZO (1), KWY (1)
- Predicates its devices cite: 29 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- U.S. Medical Products, Inc.: 11 (https://510kreport.com/company/us-medical-products)
- Consensus Orthopedics, Inc.: 5 (https://510kreport.com/company/consensus-orthopedics)
- Hayes Medical, Inc.: 3 (https://510kreport.com/company/hayes-medical)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Firms that cite its devices most
- Beijing Keyi Medical Device Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-keyi-medical-device-technology)

## Its most-cited devices
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon (2011), cited by 4
- K112285: Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate... (2011), cited by 1
- K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert (2012), cited by 1

## Recent decisions
- K150576: TGM Biolox delta Ceramic Heads (Sep 9, 2015)
- K130084: Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm (May 3, 2013)
- K121509: Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert (Nov 5, 2012)
- K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert (Oct 24, 2012)
- K112285: Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate... (Nov 4, 2011)
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon (Sep 6, 2011)

Source page: https://510kreport.com/company/tgm-medical