# KLS-Martin L.P.

- Location (FDA's records): Jacksonville, FL
- FDA decisions: 81 (1994–2026): 81 510(k) clearances
- Names in FDA's records: KLS-Martin L.P. (59); KLS Martin L.P. (20); Kls Martin GmbH + Co. KG (2)
- Product codes: JEY (19), HRS (18), MQN (13), GXN (5), DZL (4), PBJ (3), DZJ (2), PPT (2), GEI (2), DZE (2), NEI (1), ELE (1)
- 510(k) review time since 2016: median 213 days, against 120 for FDA's reviews in the same codes and years (7 of 21 faster)
- Predicates its devices cite: 206 (108 its own); citations of its devices by later devices: 195 (108 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): 21 (https://510kreport.com/company/synthes-usa)
- Walter Lorenz Surgical, Inc.: 9 (https://510kreport.com/company/walter-lorenz-surgical)
- Erbe USA, Inc.: 6 (https://510kreport.com/company/erbe-usa)
- Biomet, Inc.: 5 (https://510kreport.com/company/biomet)
- Howmedica Corp.: 4 (https://510kreport.com/company/howmedica)
- Osteomed LP: 3 (https://510kreport.com/company/osteomed)
- Patton, Boggs & Blow: 3 (https://510kreport.com/company/patton-boggs-blow)
- Stryker Leibinger GmbH & Co KG: 3 (https://510kreport.com/company/stryker-leibinger)

## Firms that cite its devices most
- Osteomed LP: 12 (https://510kreport.com/company/osteomed)
- Bioplate, Inc.: 10 (https://510kreport.com/company/bioplate)
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- Tekka: 3 (https://510kreport.com/company/tekka)
- Oral Osteodistraction, L.P.: 3 (https://510kreport.com/company/oral-osteodistraction)
- Stryker Craniomaxillofacial: 2 (https://510kreport.com/company/stryker-craniomaxillofacial)
- Kelyniam Global, Inc.: 2 (https://510kreport.com/company/kelyniam-global)
- Medicon EG: 2 (https://510kreport.com/company/medicon-eg)

## Its most-cited devices
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM) (1994), cited by 15
- K944561: Micro Osteosynthesis System (1.0) (1994), cited by 10
- K971297: Centre-Drive Drill-Free Screw (1997), cited by 9
- K032413: KLS-Martin Sternal Plating System (2003), cited by 8
- K010139: Zurich Distraction System (2001), cited by 8
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), cited by 7

## Recent decisions
- K260137: KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions (Aug 17, 2026)
- K253660: KLS Martin Pure Pectus System (Feb 20, 2026)
- K254162: KLS Martin Ixos System (Feb 20, 2026)
- K250988: KLS Martin Pure Pectus System (Dec 11, 2025)
- K250865: KLS Martin IPS Forearm System (Nov 14, 2025)
- K252573: KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (Nov 10, 2025)
- K250620: KLS Martin Ixos System (Aug 15, 2025)
- K233721: KLS Martin Drill-Free MMF Screw (Sep 17, 2024)

Source page: https://510kreport.com/company/kls-martin