# K071637: Intrinsic Therapeutics Fixation Staple

- Pathway: 510(k) (Traditional)
- Applicant: Intrinsic Therapeutics Incorporated
- Decided: Aug 3, 2007 after 49 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Conmed Linvatec Fixation Staple: named in the summary without a submission number
- (no number) Smith & Nephew Fixation Staple: named in the summary without a submission number

## Indications for use
The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as: 1. Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone. 2. Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.

Source page: https://510kreport.com/device/K071637
Methodology: https://510kreport.com/methodology