# K042460: TI - Screw Anchor SP

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Oct 29, 2004 after 49 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: 2 generations back to K943806 (1995). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012503: Metal Screw Anchor, Biomet Manufacturing, Inc. (2001) Summary page 1.
- K973775: Harpoon Suture Anchors, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs (2008), 6 descendants of its own
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own
- K193402: ALLthread PEEK Suture Anchor (2020), 0 descendants of its own
- K192942: ALLthread Titanium Suture Anchor (2020), 0 descendants of its own
- K123485: Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof (2013), 0 descendants of its own

## Indications for use
The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Source page: https://510kreport.com/device/K042460
Methodology: https://510kreport.com/methodology