# Renovis Surgical Technologies, LLC

- Location (FDA's records): Redlands, CA
- FDA decisions: 23 (2010–2019): 23 510(k) clearances
- Names in FDA's records: Renovis Surgical Technologies, LLC (9); Renovis Surgical Technologies (7); Renovis Surgical Technologies, Inc. (7)
- Product codes: OVD (5), OQG (3), MAX (3), LPH (2), KTT (1), HWC (1), OIY (1), KWY (1), KWQ (1), OVE (1), JWH (1), JDI (1)
- 510(k) review time since 2016: median 133 days, against 126 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 75 (18 its own); citations of its devices by later devices: 60 (18 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
- Biomet, Inc.: 7 (https://510kreport.com/company/biomet)
- Lanx, Inc.: 4 (https://510kreport.com/company/lanx)
- Biomet Manufacturing Corp: 3 (https://510kreport.com/company/biomet-manufacturing)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)
- Stelkast Company: 2 (https://510kreport.com/company/stelkast)
- Howmedica Corp.: 2 (https://510kreport.com/company/howmedica)

## Firms that cite its devices most
- Kyocera Medical Technologies, Inc.: 20 (https://510kreport.com/company/kyocera-medical-technologies)
- Bk Meditech, Co., Ltd.: 2 (https://510kreport.com/company/bk-meditech)
- Neurostructures, Inc.: 2 (https://510kreport.com/company/neurostructures)
- Implanet, S.A.: 2 (https://510kreport.com/company/implanet)
- Kyocera Medical Technologies Inc. (KMTI): 1 (https://510kreport.com/company/kyocera-medical-technologies-kmti)
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)
- Presidio Surgical: 1 (https://510kreport.com/company/presidio-surgical)
- Phamedica, Inc.: 1 (https://510kreport.com/company/phamedica)

## Its most-cited devices
- K111940: S 100 Pedicle Screw System (2012), cited by 7
- K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System (2013), cited by 6
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System (2014), cited by 5
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (2016), cited by 5
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System (2014), cited by 5
- K112897: Renovis Surgical Hip Joint Replacement Prosthesis (2012), cited by 4

## Recent decisions
- K190122: Renovis A200 PS Knee System as part of the Renovis A200 Knee System (Jun 20, 2019)
- K182007: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (Dec 7, 2018)
- K181655: Renovis S180 Lateral Lumbar Interbody Fusion System (Sep 11, 2018)
- K180502: S128 Anterior Lumbar Interbody Fusion (ALIF) System (Jun 14, 2018)
- K171543: Renovis Surgical Hip Replacement System (Nov 16, 2017)
- K170888: Renovis S141 Lumbar Interbody Fusion System (Aug 8, 2017)
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (Mar 16, 2016)
- K152193: Renovis Anterior Cervical Plate System (Sep 25, 2015)

Source page: https://510kreport.com/company/renovis-surgical-technologies
