# Surgtech, Inc.

- Location (FDA's records): Westlake, OH
- FDA decisions: 6 (2016–2019): 6 510(k) clearances
- Product codes: KWY (1), JDI (1), NKB (1), JWH (1), HWC (1), MAX (1)
- 510(k) review time since 2016: median 219 days, against 127 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 53 (0 its own); citations of its devices by later devices: 1 (0 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
- Synthes (Usa): 13 (https://510kreport.com/company/synthes-usa)
- I.T.S. Implantat-Technologie-Systeme GmbH: 8 (https://510kreport.com/company/its-implantat-technologie-systeme)
- Howmedica Osteonics Corp.: 6 (https://510kreport.com/company/howmedica-osteonics)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Johnson & Johnson Orthopaedics, Inc.: 1 (https://510kreport.com/company/johnson-johnson-orthopaedics)
- United Orthopedic Corporation: 1 (https://510kreport.com/company/united-orthopedic)

## Firms that cite its devices most
- Artfx Medical: 1 (https://510kreport.com/company/artfx-medical)

## Its most-cited devices
- K161894: SurgTech Trauma System (2017), cited by 1

## Recent decisions
- K191192: SurgTech GENOLL Total Knee System (Aug 1, 2019)
- K173455: SurgTech Bipolar Head System (Jun 14, 2018)
- K162125: MALUC™ Total Hip Arthroplasty System (May 10, 2017)
- K163363: SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (Apr 5, 2017)
- K161894: SurgTech Trauma System (Feb 21, 2017)
- K152200: SurgTech Interbody System (Mar 25, 2016)

Source page: https://510kreport.com/company/surgtech