# K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Jan 7, 2011 after 147 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 9 generations back to K971358 (1997). 53 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100012: Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a, Depuy Mitek, A Johnson & Johnson Company (2010) Summary page 1.
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814, Depuy Mitek, A Johnson & Johnson Company (2009) Summary page 1.
- K073412: Gryphon BR and Healix BR Anchors, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 1.
- K082282: Healix TI Anchor, Depuy Mitek, A Johnson & Johnson Co. (2008) Summary page 1.
- K071481: Healix Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew, Arthrex, Inc. (2009) Summary page 1.
- K081598: Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce Suture, Kfx Medical (2008) Summary page 1.
- K020159: Smith & Nephew Twinfix TI Quick T, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own
- K223589: Grappler Suture Anchor R3FLEX IOL System (2023), 2 descendants of its own
- K240594: Grappler Suture Anchor R3FLEX IOL System (2024), 1 descendant of its own

## Indications for use
The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder — Rotator Cuff (BR, PEEK, Titanium); Partial Thickness Rotator Cuff (BR, PEEK, Titanium); Biceps Tenodesis (PEEK, Titanium); Acromio-Clavicular Separation (PEEK, Titanium); Deltoid Repair (PEEK, Titanium) Foot/Ankle — Lateral Stabilization (PEEK, Titanium); Medial Stabilization (PEEK, Titanium); Mid-foot Reconstruction (PEEK, Titanium); Hallux Valgus Repair (BR, Titanium); Metatarsal Ligament/Tendon Repairs (PEEK, Titanium) Knee — Medial Collateral Ligament Repair (PEEK, Titanium); Lateral Collateral Ligament Repair (PEEK, Titanium); Posterior Oblique Ligament Repair (PEEK, Titanium); Iliotibial Band Tenodesis (PEEK, Titanium) Elbow — Lateral Epicondylitis Repair (PEEK, Titanium) Wrist — Scapholunate Ligament Reconstruction (PEEK, Titanium) Hip — Capsular Repair (PEEK, Titanium); Acetabular Labral Repair (PEEK, Titanium)

Source page: https://510kreport.com/device/K102298
Methodology: https://510kreport.com/methodology