# K070389: Peek Knotless Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine, Inc.
- Decided: Aug 9, 2007 after 181 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943806 (1995). 12 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 22 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 1.
- K041274: Resorbable Interference Screw, Arthrotek, Inc. (2004) Summary page 1.
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K110230: Rog Knotless Suture Anchor (2011), 7 descendants of its own
- K111590: Rog Suture Anchor, Rog Knotless Suture Anchor (2011), 5 descendants of its own
- K113299: Rog Suture Anchor (2011), 2 descendants of its own
- K112991: Modified Rog Suture Anchor (2011), 1 descendant of its own
- K230517: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) (2023), 0 descendants of its own

## Recalls of this device
- Sep 9, 2009 · Not classified · Z-0191-2010: These anchors may be difficult to remove, or may not detach from the inserter shaft.

## Indications for use
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement The PEEK Knotless Anchors are single-use devices.

Source page: https://510kreport.com/device/K070389
Methodology: https://510kreport.com/methodology