Who is the manufacturer of ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM?

Wrightmedicaltechnologyinc filed the 510(k) submission for ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM (K963217).

What is the FDA product code for ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM

Q: What are the predicate devices for ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM?

ANCHORLOK™ Polyester Suture Soft Tissue Anchor System.

K963217 · Wrightmedicaltechnologyinc · MBI · Oct 2, 1996 · Orthopedic

Device Facts

Record ID	K963217
Device Name	ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
Applicant	Wrightmedicaltechnologyinc
Product Code	MBI · Orthopedic
Decision Date	Oct 2, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following: - 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; - repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - 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; - repair of foot/ankle instability secondary to 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. Surgeon-operated in clinical/surgical settings. Device provides mechanical fixation for soft tissue-to-bone repair; surgeon threads preferred suture through anchor. Facilitates stabilization of ligaments and tendons across multiple joints; aids healing by securing tissue to bone.

Clinical Evidence

Bench testing only. 7.5mm and 2.5mm anchors tested per Draft Guidance Document for Testing Bone Anchor Devices (April 1, 1993). Results indicate performance meets or exceeds in vivo performance of predicate 5.0mm anchor and USP standards for Nylon™ monofilament sutures.

Technological Characteristics

Titanium alloy bone anchor; disposable wire leader; disposable protective sleeve. Single-use, sterile. Mechanical fixation device. No software or electronic components.

Indications for Use

Indicated for repair of soft tissue instability in shoulder, elbow, hand/wrist, knee, and foot/ankle, including ligament/tendon tears, separations, and reconstructions.

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™ Polyester Suture Soft Tissue Anchor System

Related Devices

K964786 — ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Feb 6, 1997
K183279 — HEALIX Ti ANCHOR with DYNACORD · Medos International SARL · Feb 21, 2019
K141011 — G-FORCE GEN 2 SUTURE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Jul 30, 2014
K023021 — MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T · Smith & Nephew, Inc. · Oct 4, 2002
K020159 — SMITH & NEPHEW TWINFIX TI QUICK T · Smith & Nephew, Inc. · Mar 26, 2002

Submission Summary (Full Text)

{0} SEP-30-96 12:44 FROM:WRIGHT MEDICAL CR AFFAIRS PAGE 4/7 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 OCT - 2 1996 K963217 510(k) Summary Contact Person: Cristie Manuel Date Prepared: September 30, 1996 Trade/Proprietary Name: ANCHORLOK™ II Soft Tissue Anchor System Common Name: Fastener, fixation, nondegradable, soft tissue Product Classification: Class II Predicate Device: ANCHORLOK™ Polyester Suture Soft Tissue Anchor System This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. Description/Intended Use The ANCHORLOK™ II Soft Tissue Anchor System is a single use, sterile kit consisting of a bone anchor with a disposable wire leader and disposable protective sleeve. The surgeon uses suture according to preference. The anchor is manufactured from titanium alloy. The ANCHORLOK™ II Soft Tissue Anchor System is indicated for the following: - 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; - repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; - repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament; - 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; - 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 Testing Summary The 7.5mm anchor was tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the 7.5mm anchor can be expected to meet or exceed the in vivo performance of the 5.0mm anchor. The 2.5mm and 7.5mm ANCHORLOK™ II Soft Tissue Anchors were tested according to Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993. The conclusion from this test is that the in vivo performance of Nylon™ monofilament sutures meets or exceeds the values established by USP for these devices.