510(k) Report

FDA applicant

Intrinsic Therapeutics

Woburn, MA3 decisions2007–20201 recall

FDA records 3 decisions for Intrinsic Therapeutics (Woburn, MA) from 2007 to 2020: 2 510(k) clearances and 1 original PMA approval. Most are in product codes QES (Reherniation Reduction Device) and JDR (Staple, Fixation, Bone). 1 recall is linked to its devices.

FDA’s records also spell it “Intrinsic Therapeutics Incorporated”, “Intrinsic Therapeutics, Inc.”.

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 Intrinsic Therapeutics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12019: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Intrinsic Therapeutics’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

Other applicant names beginning “Intrinsic”

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