510(k) Report

FDA applicant

Cayenne Medical, Inc.

Scottsdale, AZ23 decisions2006–20191 recall

FDA records 23 decisions for Cayenne Medical, Inc. (Scottsdale, AZ) from 2006 to 2019: 23 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Cayenne Medical”.

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 Cayenne Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 22008: 12009: 32011: 12012: 52013: 22015: 32016: 12017: 12018: 12019: 1
2007high 5 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cayenne Medical, Inc.’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?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue14decisions
  • HWCScrew, Fixation, Bone6decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene3decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 69 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 44 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 8 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.

  • K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 20124cite it
  • K083607Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MMCayenne Medical, Inc. · 20093cite it
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 20152cite it
  • K172186BioWick X Implant with DriverCayenne Medical, Inc. · 20171cites it
  • K083612Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MMCayenne Medical, Inc. · 20091cites it
  • K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K192428AFX Femoral Implant with InserterCayenne Medical · 2019
  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017
  • K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015
  • K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock…Cayenne Medical, Inc. · 2015
  • K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc. · 2015
  • K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MMCayenne Medical, Inc. · 2013

All 22 as Cayenne Medical, Inc. →The one decision as Cayenne Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083612AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24…Jul 11, 2013Class II