# K2m, Inc.

- Location (FDA's records): Leesburg, VA
- FDA decisions: 127 (2005–2026): 127 510(k) clearances
- Names in FDA's records: K2m, Inc. (100); K2m (16); K2m, LLC (8); K2m, Incorporated (3)
- Product codes: NKB (20), KWQ (20), MNI (15), MAX (13), KWP (12), MQP (8), OLO (7), OVD (7), OSH (6), NKG (5), OWI (3), ODP (3)
- 510(k) review time since 2016: median 88 days, against 97 for FDA's reviews in the same codes and years (24 of 41 faster)
- Predicates its devices cite: 548 (315 its own); citations of its devices by later devices: 499 (315 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 28 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuy Spine, Inc.: 22 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek USA, Inc.: 17 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stryker Corp.: 12 (https://510kreport.com/company/stryker)
- Synthes (Usa): 12 (https://510kreport.com/company/synthes-usa)
- Globus Medical, Inc.: 12 (https://510kreport.com/company/globus-medical)
- Synthes Spine: 11 (https://510kreport.com/company/synthes-spine)
- Depuyacromed: 6 (https://510kreport.com/company/depuyacromed)

## Firms that cite its devices most
- Stryker Spine: 31 (https://510kreport.com/company/stryker-spine)
- Reliance Medical Systems, LLC: 15 (https://510kreport.com/company/reliance-medical-systems)
- CarboFix Orthopedics, Ltd.: 8 (https://510kreport.com/company/carbofix-orthopedics)
- Osseus Fusion Systems, LLC: 7 (https://510kreport.com/company/osseus-fusion-systems)
- K7, LLC: 6 (https://510kreport.com/company/k7)
- Nexxt Spine, LLC: 6 (https://510kreport.com/company/nexxt-spine)
- Spineart: 5 (https://510kreport.com/company/spineart)
- Zsfab, Inc.: 4 (https://510kreport.com/company/zsfab)

## Its most-cited devices
- K070229: Range Spinal System (2007), cited by 24
- K082698: Aleutian Ibf System (2009), cited by 22
- K160125: Cascadia Interbody System (2016), cited by 21
- K080792: K2M Cocr Rod (2008), cited by 18
- K052398: Mesa Spinal System (2005), cited by 17
- K150481: Cascadia Interbody System (2015), cited by 16

## Recent decisions
- K260546: Q Pedicle Instruments (Mar 17, 2026)
- K253545: Vulcan Spinal System (Feb 10, 2026)
- K252873: Q Interbody Instruments (Feb 6, 2026)
- K211320: CAPRI Corpectomy Cage System (Feb 24, 2022)
- K202528: Cannulated Power Driver Attachment (Oct 26, 2020)
- K201006: K2M Navigation Instruments (Aug 7, 2020)
- K193203: MOJAVE Expandable Interbody System (Feb 18, 2020)
- K193129: Yukon OCT Spinal System (Feb 7, 2020)

Source page: https://510kreport.com/company/k2m