ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
Device Facts
| Record ID | K964786 |
|---|---|
| Device Name | ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | MBI · Orthopedic |
| Decision Date | Feb 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The ANCHORLOK™ RL Soft Tissue Anchor System is intended for use: - In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; - In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - Female urinary incontinence due to urethral hypermobility; - In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis; - In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Device Story
Single-use, sterile kit; includes titanium alloy bone anchor, disposable wire leader, and protective sleeve. Used by surgeons in clinical settings for soft tissue-to-bone fixation. Anchor implanted into bone to secure tendons or ligaments; provides mechanical fixation to facilitate healing of instability or tears. Benefits include restoration of joint stability and treatment of urinary incontinence.
Clinical Evidence
Bench testing only. In vitro pullout strength testing in the pubis performed to compare subject device against Statak™ predicate.
Technological Characteristics
Material: Titanium alloy. Components: Bone anchor, disposable wire leader, disposable protective sleeve. Single-use, sterile kit.
Indications for Use
Indicated for patients requiring soft tissue-to-bone fixation for repair of instability or tears in shoulder, elbow, hand/wrist, knee, and foot/ankle, and for female urinary incontinence due to urethral hypermobility.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- ANCHORLOK™ RL Soft Tissue Anchor System (manufacturer: Wright Medical Technology, Inc.)
- Statak™ Soft Tissue Attachment Device (manufacturer: Zimmer)
Related Devices
- K963217 — ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Oct 2, 1996
- K183279 — HEALIX Ti ANCHOR with DYNACORD · Medos International SARL · Feb 21, 2019
- K141011 — G-FORCE GEN 2 SUTURE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Jul 30, 2014
- K963200 — QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Oct 2, 1996
- K020159 — SMITH & NEPHEW TWINFIX TI QUICK T · Smith & Nephew, Inc. · Mar 26, 2002
