# K052572: Anspach Knotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Dec 5, 2005 after 77 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Anspach Suture Anchor: named in the summary without a submission number

## Recalls of this device
- Nov 28, 2012 · Class II · Z-1915-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1875-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1916-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1876-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

## Indications for use
The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic Knotless Anchor is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments. The Anspach Arthroscopic Knotless Anchor is used with specific brarns and types of suture materials including: Arthrotek "MaxBraid"; Smith & Nephew "UltraBraid"; Opus Medical "Magnum Wire"; and Linvetec "Herculine. Suture materials identified as "Braided # 2 polyester" and Arthrex # 2 "Fiberwire" are not recommended for use with The Anspach Arthroscopic Knotless Anchor.

Source page: https://510kreport.com/device/K052572
Methodology: https://510kreport.com/methodology