# K102262: Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction Tool

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Oct 21, 2010 after 72 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: 6 generations back to K961555 (1996). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081893: Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500, Arthrocare Corp. (2008) Summary page 1.
- K100457: Opus Speedscrew System, Arthrocare Corp. (2010) Summary page 1.
- K092133: Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N, Arthrocare Corp. (2009) Summary page 1.
- K101184: Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006, Arthrocare Corp. (2010)

## Most influential descendants
- K110164: 5.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction Tool (2011), 1 descendant of its own
- K110781: 5.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction Tool, 5.5 / 6.5MM Punch Tap (2011), 0 descendants of its own

## Indications for use
The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: H-allux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Source page: https://510kreport.com/device/K102262
Methodology: https://510kreport.com/methodology