510(k) Report

FDA applicant

Cartiva, Inc.

Alpharetta, GA4 decisions2014–20191 recall

FDA records 4 decisions for Cartiva, Inc. (Alpharetta, GA) from 2014 to 2019: 3 510(k) clearances and 1 original PMA approval. Most are in product codes QBO (Instruments Designed For Press-Fit…) and PNW (Prosthesis, Metatarsophalangeal Joint…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is 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 Cartiva, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12016: 12018: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2014high 1 (2024) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Cartiva, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cartiva, 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?

  • QBOInstruments Designed For Press-Fit Osteochondral Implants2decisions
  • PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1decision
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K142490ProxiFuse Hammer Toe DeviceCartiva, Inc. · 20141cites it

What has FDA decided for it lately?

  • K192156Cartiva SCI instrumentation setCartiva, Inc. · 2019
  • K181348Cartiva SCI Disposable Instrumentation SetCartiva, Inc. · 2018
  • P150017Cartiva Synthetic Cartilage ImplantCartiva, Inc. · 20161 recall
  • K142490ProxiFuse Hammer Toe DeviceCartiva, Inc. · 2014

All 4 as Cartiva, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P150017Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm)…Oct 31, 2024Class II