# K994313: Modification to Bone Anchor and Kit (Bak)

- Pathway: 510(k) (Special)
- Applicant: Axya Medical, Inc.
- Decided: Jan 13, 2000 after 22 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932591 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992405: Axya Medical Inc, Bone Anchor System and Kit- (Bak), Axya Medical, Inc. (1999) Summary page 2.
- K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls), Axya Medical, Inc. (1998) Summary page 1.
- K983108: Suture Welding System and Kit (SWK), Axya Medical, Inc. (1998) Summary page 2.

## Indications for use
The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include: Shoulder procedures (e.g. Rotator cuff repair) Knee procedures (e.g. Patellar ligament / tendon avulsion repair) Ankle procedures (e.g. Achilles tendon reconstruction and repair) Foot procedures (e.g. Hallux valgus reconstruction) Elbow procedures (e.g. Biceps tendon reattachment) Bladder neck suspension (female urinary incontinence due to urethral hypermobility) The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

Source page: https://510kreport.com/device/K994313
Methodology: https://510kreport.com/methodology