# K102143: Suspension Acromioclavicular (AC) Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Suspension Orthopaedic Solutions, LLC
- Decided: Dec 8, 2010 after 131 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K003227 (2001). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060970: Axyaloop Nonabsorbable Bone Anchor, Axya Medical, Inc. (2006) Summary page 1.
- K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor, Axya Medical, Inc. (2005) Summary page 1.
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 1.
- K960825: LM Anchor or Other Proprietary Name, Li Medical Technologies, Inc. (1996) Summary page 1.

## Indications for use
The Suspension™ Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

Source page: https://510kreport.com/device/K102143
Methodology: https://510kreport.com/methodology