# K193402: ALLthread PEEK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 5, 2020 after 90 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943806 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060693: Microstrike and Allthread Peek Suture Anchor, Arthrotek, Inc. (2006) Summary page 4.
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs, Biomet Manufacturing, Inc. (2008) Summary page 4.

## Indications for use
The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Source page: https://510kreport.com/device/K193402
Methodology: https://510kreport.com/methodology