# K961555: Acufex Tag Bioabsorbable Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Jul 10, 1996 after 79 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.
584 later devices descend from it; 2 cite it directly.
0 of 585 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) Acufex TAG Anchors (non-absorbable): named in the summary without a submission number
- (no number) Mitek Mini GII Anchors: named in the summary without a submission number

## Most influential descendants
- K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318 (2003), 478 descendants of its own
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor (2006), 477 descendants of its own
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), 283 descendants of its own
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew (2007), 227 descendants of its own
- K972783: Biofix Biodegradable Threaded Suture Anchor (1998), 166 descendants of its own

## Indications for use
The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue. The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow. These additional indications employ the following screw types and sizes: Size/Style — Indication 3.7mm Rod II — Foot, ankle, elbow 3.7mm Wedge — Foot, ankle, elbow 3.0mm Wedge — Foot, ankle, elbow 3.0mm Wedge Mini-TAG — Foot, ankle 2.0mm Wedge Mini-TAG — Foot, ankle

Source page: https://510kreport.com/device/K961555
Methodology: https://510kreport.com/methodology