# K000019: Single Size Tendon Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Medist International
- Decided: Mar 29, 2000 after 85 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
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices 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) Wright Medical Technology Swanson Tendon Spacer: named in the summary without a submission number

## Most influential descendants
- K053655: Tendon Wrap Tendon Protector (2006), 39 descendants of its own
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K061473: Surgi-Wrap Mast Bioresorbable Sheet (2006), 13 descendants of its own
- K063648: Surgi-Wrap Mast Tendon Sheet (2007), 12 descendants of its own

## Indications for use
Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.

Source page: https://510kreport.com/device/K000019
Methodology: https://510kreport.com/methodology