STRYKER XCEL ANCHOR SYSTEM

K023013 · Stryker Endoscopy · HWC · Feb 26, 2003 · Orthopedic

Device Facts

• Record ID: K023013
• Device Name: STRYKER XCEL ANCHOR SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: HWC · Orthopedic
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Bankart repair, SLAP lesion repair, Rotator cuff repair, Capsular shift repair, Biceps tenodesis, Acromio-clavicular separation; Elbow: Biceps tendon reattachment; Foot & Ankle: Achilles tendon repair/reconstruction, Lateral stabilization, Medial stabilization; Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Joint capsule closure to anterior proximal tibia, Posterior oblique ligament or joint capsule to tibia repair, Extra capsular reconstruction/ITB tenodesis, Patellar ligament and tendon avulsion repairs. The Stryker XCEL Anchor is intended for single-use only.

Device Story

Stryker XCEL Anchor System consists of Poly L-lactic acid (PLLA) anchor pre-threaded with nonabsorbable braided polyester suture; pre-assembled on disposable inserter. Used in orthopedic surgery to secure soft tissue to bone. Surgeon implants anchor into pre-drilled bone hole using provided instrumentation (drill, soft-tissue guide). Device provides mechanical fixation of soft tissue via suture. Used in clinical settings (OR); operated by physicians. Benefits include secure tissue-to-bone attachment during reconstructive procedures.

Clinical Evidence

Bench testing only. Device biocompatibility confirmed per ISO 10993 and G95-1. Sterilization validated to SAL 10^-6 using Ethylene oxide per EN550. Performance testing showed substantial equivalence to predicate.

Technological Characteristics

Materials: Poly L-lactic acid (PLLA) anchor, braided polyester suture. Form factor: Pre-assembled anchor on disposable inserter. Sterilization: Ethylene oxide (EN550). Biocompatibility: ISO 10993, G95-1. Packaging: ASTM 4169.

Indications for Use

Indicated for securing soft tissue to bone in orthopedic surgical procedures of the shoulder, elbow, foot, ankle, and knee. Intended for single-use only.

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

• Mitek Panalok 3.5mm Absorbable Anchor System (K970896)

Submission Summary (Full Text)

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K0230/3

Page 11

FEB 2 6 2003

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### De ice Name

Classification Name:

Common and Usual Name: Proprietary Name:

Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Suture Anchor (MAI) Stryker XCEL Anchor System

## Prodicate Device

Mi ek Panalok 3.5mm Absorbable Anchor System, (#K970896), currently marketed by Mitek Prc ducts/lithicon (Westwood, MA).

### Su nmarv

Th s summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

Th > Stryker XCEL Anchor System is intended to be implanted within a pre-drilled bone hole site and pr vide a means for firmly securing soft tissue to bone using suture. The use of suture anchors is common in >rthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Jo irnal of Arthroscopic and Related Surgery.

The Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with nonab torbable, braided polyester surgical suture, and pre-assembled on a disposable inserter. Stryker in: trumentation, drill and soft-tissue guide/drill guide, will be used to install the Stryker XCEL Anchor.

The Stryker XCEL Anchor System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Ethylene oxide (EN550), including limits for Ethylene O: ide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per IS 3-10993 and G95-1. The Stryker XCEL Anchor is substantially equivalent in intended use, safety, and ef icacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

Tl e Stryker XCEL Anchor System is considered substantially equivalent to the Mitek Panalok 3.5mm A' sorbable Anchor System.

Contact:

Date: December 11, 2002

Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 [phone] x.2259

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Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K023013

Trade/Device Name: Stryker XCEL Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic fixation fastener Regulatory Class: II Product Code: HWC Dated: December 11, 2002 Received: December 12, 2002

Dear Ms. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Alisa Miller

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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De zember 11, 2002

510(k) Number: K023013

# INDICATION FOR USE:

The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as:

| Shoulder: | Elbow: | Foot & Ankle: |
|-------------------------------|----------------------------|---------------------------------------|
| Bankart repair | Biceps tendon reattachment | Achilles tendon repair/reconstruction |
| SI AP lesion repair | | Lateral stabilization |
| Rotator cuff repair | | Medial stabilization |
| Capsular shift repair | | |
| Biceps tenodesis | | |
| Acromio-clavicular separation | | |

Knee:

Medial collateral ligament repair La teral collateral ligament repair Joint carsule closure to anterior proximal tibia P sterior oblique ligament or joint capsule to tibia repair Extra capsular reconstruction/ITB tenodesis P: tellar ligament and tendon avulsion repairs

The Stryker XCEL Anchor is intended for single-use only.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODF)

Mark M
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

Number K023013

Over-the-Counter Use No

Prescription Use (Fer 21 CFR 801.109)

OR