# K243477: Universal Tendon Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Askorn Medical
- Decided: Jan 10, 2025 after 63 days
- Product code: HXA (Prosthesis, Tendon, Passive)
- Device class: 2
- Regulation: 21 CFR 888.3025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000019 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000019: Single Size Tendon Spacer, Medist International (2000)

## Indications for use
Universal Tendon Spacer is a medical device used in the reconstruction of the flexor and extensor tendons of the hand. The device is implantable for 2 to 6 months and intended for single use. This device is used for: Adherent or mutilated tendons following trauma or a primary repair which has failed. Absence of the tendon sheath. Non-functioning, mutilated or adherent tendon pulleys. Ruptured tendons. The patient must be in good health with sufficient tissue cover. Sufficiently healthy joints, bone marrow and adequate vascular and neuro-muscular conditions are also necessary to facilitate a definite functional improvement using this reconstruction technique. The patient must be cooperative, especially concerning the need for rehabilitation measures.

Source page: https://510kreport.com/device/K243477
Methodology: https://510kreport.com/methodology