# Skeletal Kinetics, LLC

- Location (FDA's records): Cupertino, CA
- FDA decisions: 10 (2003–2017): 10 510(k) clearances
- Product codes: MQV (6), GXP (3), MTJ (1)
- Predicates its devices cite: 21 (9 its own); citations of its devices by later devices: 16 (9 its own)
- Recalls linked to its devices: 61 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Biomatlante: 1 (https://510kreport.com/company/biomatlante)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Ceremed, Inc.: 1 (https://510kreport.com/company/ceremed)
- Lukens Corp.: 1 (https://510kreport.com/company/lukens)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Dimensional Bioceramics, LLC: 4 (https://510kreport.com/company/dimensional-bioceramics)
- Orthocon, Inc.: 2 (https://510kreport.com/company/orthocon)
- Hemostasis, LLC: 1 (https://510kreport.com/company/hemostasis)

## Its most-cited devices
- K051123: Callos Impact and Inject Bone Void Filler (2005), cited by 5
- K111538: Skaffold Cis (2011), cited by 3
- K030554: Callos (2003), cited by 3
- K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler (2012), cited by 1
- K051784: Osteovation CMF Bone Void Filler (2005), cited by 1
- K132211: Skaffold NMX Bone Void Filler (2014), cited by 1

## Recent decisions
- K162864: OsteoVation Impact (Jan 13, 2017)
- K132211: Skaffold NMX Bone Void Filler (Aug 4, 2014)
- K120354: Beta-TCP Granules (Mar 21, 2013)
- K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler (Feb 7, 2012)
- K111538: Skaffold Cis (Oct 25, 2011)
- K100986: Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation (Jul 20, 2010)
- K051784: Osteovation CMF Bone Void Filler (Jul 20, 2005)
- K051123: Callos Impact and Inject Bone Void Filler (Jun 3, 2005)

Source page: https://510kreport.com/company/skeletal-kinetics