# K071157: Stryker Peek and Titanium Soft Eyelet Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Sep 17, 2007 after 145 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990987 (2000). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K151201: Stryker ICONIX with Needles (2015), 10 descendants of its own
- K173074: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor (2018), 5 descendants of its own
- K231078: All-Suture Anchor (2023), 3 descendants of its own
- K231278: Knotless Suture Anchor (2023), 3 descendants of its own
- K233468: Iconix Anchor (2023), 1 descendant of its own

## Recalls of this device
- Aug 20, 2009 · Not classified · Z-0618-2011: Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal s
- Feb 7, 2008 · Not classified · Z-1536-2008: Product package may crack and cause loss of sterility.
- Feb 7, 2008 · Not classified · Z-1533-2008: Product package may crack and cause loss of sterility.
- Feb 7, 2008 · Not classified · Z-1535-2008: Product package may crack and cause loss of sterility.
- Feb 7, 2008 · Not classified · Z-1534-2008: Product package may crack and cause loss of sterility.

## Indications for use
The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended for use in the following procedures: Shoulder: * Rotator Cuff Repair * Bankart Repair * SLAP Lesion Repair * Biceps Tenodesis * Acromio-Clavicular Separation Repair * Deltoid Repair * Capsular Shift/Capsulolabral Reconstruction. Foot and Ankle: * Lateral Stabilization * Medial Stabilization * Achilles Tendon Repair * Hallux Valgus Reconstruction * Midfoot Reconstruction * Metatarsal Ligament Repair. Knee: * Anterior Cruciate Ligament Repair * Medial Collateral Ligament Repair * Lateral Collateral Ligament Repair * Patellar Tendon Repair * Posterior Oblique Ligament Repair * Illiotibial Band Tenodesis Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment * Ulnar or Radial Collateral Ligament Reconstruction Pelvis: Bladder Neck Suspension Procedures The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Source page: https://510kreport.com/device/K071157
Methodology: https://510kreport.com/methodology