510(k) Report

FDA applicant

Skeletal Kinetics, LLC

Cupertino, CA10 decisions2003–201761 recalls

FDA records 10 decisions for Skeletal Kinetics, LLC (Cupertino, CA) from 2003 to 2017: 10 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and GXP (Methyl Methacrylate For Cranioplasty). Its devices cite 21 predicates, 9 of them its own earlier devices. 61 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Skeletal Kinetics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010: 12011: 12012: 12013: 12014: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

58in 2020

2015: 12019: 22020: 58
2007high 58 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Skeletal Kinetics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Skeletal Kinetics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound6decisions
  • GXPMethyl Methacrylate For Cranioplasty3decisions
  • MTJWax, Bone1decision

Whose devices does it build on?

Its devices cite 21 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 20055cite it
  • K111538Skaffold CisSkeletal Kinetics, LLC · 20113cite it
  • K030554CallosSkeletal Kinetics, LLC · 20033cite it
  • K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC · 20121cites it
  • K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 20051cites it
  • K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 20141cites it

What has FDA decided for it lately?

  • K162864OsteoVation ImpactSkeletal Kinetics, LLC · 20177 recalls
  • K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC · 2014
  • K120354Beta-TCP GranulesSkeletal Kinetics, LLC · 2013
  • K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC · 20123 recalls
  • K111538Skaffold CisSkeletal Kinetics, LLC · 2011
  • K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC · 201011 recalls
  • K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 200513 recalls
  • K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC · 200517 recalls

All 10 as Skeletal Kinetics, LLC →

What has been recalled?

61 recalls linked to its devices; the latest:

  • K042072SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI…Apr 6, 2020Class II
  • K112383SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage…Apr 6, 2020Class II
  • K112383EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product…Apr 6, 2020Class II
  • K042072SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage…Apr 6, 2020Class II
  • K100986ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos…Apr 6, 2020Class II
  • K100986OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 -…Apr 6, 2020Class II

Other applicant names beginning “Skeletal”

FDA records each applicant name separately; these may or may not be the same firm.

Skeletal Dynamics, Inc. 40The Skeletal Design Partnership, Ltd. 1