# K253538: TeKBrace Knotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Theramicro
- Decided: Mar 6, 2026 after 113 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: 13 generations back to K792022 (1979). 144 ancestors in all.
No later device cites it as a predicate yet.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 5.
- K201636: Hercules Suture Anchor System, In2bones USA, LLC (2020) Summary page 5.
- K200503: ATL Anchors, International Life Sciences (2020) Summary page 5.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 6.
- K230435: Arthrex 3.9 mm SwiveLock Anchor, Arthrex, Inc. (2023) Summary page 6.

## Cited in the summary but kept off the family tree
- K203435: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System, Nihon Kohden Corporation (2021). Our reading of the summary gave K203435, FDA’s number for Nihon Kohden Life Scope G5 Bedside Monitoring System… (Nihon Kohden Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Arthrex SwiveLok Anchors”. Kept off the family tree. Summary page 6.

## Indications for use
TheraMicro TeKBrace Knotless Anchors are intended for use in the following applications: Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus reconstruction, Midfoot reconstruction , Metatarsal Ligament/Tendon Repair, and Bunionectomy. Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 Only), Medial collateral and Lateral collateral ligament repair, Patellar tendon repair and Posterior oblique ligament repair, Extra Capsular Reconstruction, llliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Quadriceps Tendon Repair (4.75 Only), Meniscal Root Repair (4.75 Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 only), MPFL Repair/Reconstruction (3.9 Only) Hand and Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament and Ulnar collateral ligament reconstruction. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction. Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm only), and Proximal Hamstring Repair (4.75 - 5.5 only).

Source page: https://510kreport.com/device/K253538
Methodology: https://510kreport.com/methodology