510(k) Report

FDA applicant

Conformis, Inc.

Billerica, MA60 decisions2005–202335 recalls

FDA records 60 decisions for Conformis, Inc. (Billerica, MA) from 2005 to 2023: 60 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and HSX (Prosthesis, Knee, Femorotibial…). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 179 predicates, 143 of them its own earlier devices. 35 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 Conformis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

6in 2023

2007: 32008: 12009: 22010: 12011: 32012: 62013: 42014: 62015: 12016: 52017: 22018: 12019: 32020: 42021: 62022: 32023: 6
2007high 6 (2012) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2009: 32012: 12014: 12015: 112016: 32017: 12018: 22019: 52020: 42022: 12023: 12024: 12025: 1
2007high 11 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer40decisions
  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer8decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4decisions
  • NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented…2decisions
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…2decisions
  • MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated…2decisions

Also: OOG (1), KCT (1).

How long do its 510(k) reviews take?

Since 2016, its 28 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 19 of its 28 were faster than that.

Whose devices does it build on?

Its devices cite 179 predicates; 143 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 150 times; 143 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.

  • K043570Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 20059cite it
  • K094050Itotal CR Knee Replacement SystemConformis, Inc. · 20108cite it
  • K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 20117cite it
  • K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 20065cite it
  • K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 20135cite it
  • K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 20115cite it

What has FDA decided for it lately?

  • K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS)…Conformis, Inc. · 2023
  • K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee…Conformis, Inc. · 2023
  • K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 2023
  • K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc. · 20231 recall
  • K231178ACTERA™ hip systemConformis, Inc. · 2023
  • K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertConformis, Inc. · 2023
  • K221104Actera™ hip systemConformis, Inc. · 20221 recall
  • K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and…Conformis, Inc. · 2022

All 60 as Conformis, Inc. →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K202484restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number…Mar 25, 2025Class II
  • K210191Identity Imprint PS Tibial Tray Size 4: Lot 540287Mar 11, 2024Class II
  • K190904Conformis Hip-Screw-6.5MM X 25MM, Sterile EOJun 16, 2023Class II
  • K210809iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number…Feb 22, 2022Class II
  • K192198iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System…Sep 21, 2020Class II
  • K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant…Jul 20, 2020Class II