STRYKER BIOZIP SUTURE ANCHOR SYSTEM

• K Number: K041305
• Device Name: STRYKER BIOZIP SUTURE ANCHOR SYSTEM
• Manufacturer: Stryker Endoscopy
• Date Cleared: 2004-06-14 ( 28 days)
• Product Code: MAI
• Regulation Number: 888.3030
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K023192
• Predicate For: K070758

Intended Use

The Styker BioZip Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as:

Shoulder:
Rotator cuff repair
Bankart repair
SLAP lesion repair
Acromio-clavicular sepaeration repair
Capsular shift/capsulolabral reconstruction
Biceps tenodesis
Deltoid repair

Knee:
Extra capsular repairs
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Illiotibial band tenosis
Patellar tendon repair

Elbow, Wrist, Hand:
Scapholunate ligament reconstruction
Ulnar collateral ligament reconstruction radial
Collateral ligament reconstruction
Biceps tendon reattachment

Foot & Ankle
Medial instability repair/reconstruction
Lateral instability repair/reconstruction
Achilles tendon repair/reconstruction
Midfoot reconstruction
Hallux valgus reconstruction

Pelvis:
Bladder neck suspension procedures

The Stryker BioZip Suture Anchor System is intended for single-use only.

Device Description

The line extension of the Stryker BioZip Suture Anchor System consists of a Poly L-lactic acid (PLLA) screw-in type anchor pre-threaded with non-absorbable braided polyethylene surgical sutures, and pre-assembled on a disposable inserter.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Stryker BioZip Suture Anchor System), but it does not describe an acceptance criteria study or present detailed performance data that would typically be found in such a study. Instead, it states that the device is "substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device" and that "The subject device was shown to have substantially equivalent performance when compared to the predicate device."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.