# K964359: Avanta Orthopaedics Tendon Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Mar 25, 1997 after 144 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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 Silastic Tendon Spacer: named in the summary without a submission number

## Most influential descendants
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## Indications for use
Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.

Source page: https://510kreport.com/device/K964359
Methodology: https://510kreport.com/methodology