# Synthes Spine

- Location (FDA's records): West Chester, PA
- FDA decisions: 54 (1995–2012): 54 510(k) clearances
- Names in FDA's records: Synthes Spine (36); Synthes Spine Co.Lp (18)
- Product codes: KWQ (13), NKB (10), MNI (7), MQP (6), OVE (5), KWP (4), OMR (2), MNH (2), MAX (2), NQW (1), HAW (1), OVD (1)
- Predicates its devices cite: 177 (60 its own); citations of its devices by later devices: 366 (60 its own)
- Recalls linked to its devices: 19 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 71 (https://510kreport.com/company/synthes-usa)
- Depuy Spine, Inc.: 5 (https://510kreport.com/company/depuy-spine)
- Synthes: 4 (https://510kreport.com/company/synthes)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Spinemedica, LLC: 2 (https://510kreport.com/company/spinemedica)
- Replication Medical, Inc.: 2 (https://510kreport.com/company/replication-medical)
- Interpore Cross Intl.: 2 (https://510kreport.com/company/interpore-cross-intl)

## Firms that cite its devices most
- Medacta International S.A.: 18 (https://510kreport.com/company/medacta-international)
- Globus Medical, Inc.: 12 (https://510kreport.com/company/globus-medical)
- K2m, Inc.: 11 (https://510kreport.com/company/k2m)
- Synthes (Usa): 10 (https://510kreport.com/company/synthes-usa)
- Synthes (USA) Products, LLC: 9 (https://510kreport.com/company/synthes-usa-products)
- Zavation, LLC: 8 (https://510kreport.com/company/zavation)
- Stryker Spine: 8 (https://510kreport.com/company/stryker-spine)
- Stryker Corp.: 8 (https://510kreport.com/company/stryker)

## Its most-cited devices
- K000536: Synthes Anterior CSLP System (2000), cited by 40
- K072791: Oracle Spacer, Opal Spacer (2007), cited by 29
- K072253: Synfix-LR Spacer (2007), cited by 28
- K082572: Uss Iliosacral, Uss Polyaxial (2008), cited by 22
- K992739: Click'x (2000), cited by 21
- K032534: Synthes Afs (2004), cited by 18

## Recent decisions
- K122211: Synthes Navigable Pedicle Preparation Instruments (Dec 17, 2012)
- K120838: Synthes Matrix System (Jul 31, 2012)
- K121852: Synthes Zero-P Variable Angle (VA) (Jul 25, 2012)
- K111048: Synthes Scout Tack Fixation (Jun 14, 2012)
- K120928: Synthes Matrix System (May 18, 2012)
- K120571: Synthes Uss Connector (May 14, 2012)
- K113149: Synthes Uss Connectors (Feb 1, 2012)
- K113044: Synthes Mirs (Dec 21, 2011)

Source page: https://510kreport.com/company/synthes-spine