MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM

K041307 · Stryker Endoscopy · MAI · Jun 14, 2004 · Orthopedic

Device Facts

• Record ID: K041307
• Device Name: MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: MAI · Orthopedic
• Decision Date: Jun 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Stryker XCEL Anchor System; bioabsorbable soft tissue-to-bone fixation device. Comprises Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable braided polyethylene surgical suture; pre-assembled on disposable inserter. Used by surgeons in orthopedic procedures (shoulder, elbow, knee, foot/ankle) to secure soft tissue to bone. Provided sterile for single-use. Device facilitates tissue reattachment; aids healing/stabilization. No complex electronics or software.

Clinical Evidence

Bench testing only. Device biocompatibility per ISO-10993-1 and G95-1. Sterilization validated per ANSI/AAMI/ISO 11135 to SAL 10^-6. Packaging validated per ASTM 4169.

Technological Characteristics

Material: Poly L-lactic acid (PLLA) anchor; non-absorbable braided polyethylene suture. Form factor: Pre-assembled on disposable inserter. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135). Biocompatibility: ISO-10993-1, G95-1. Packaging: ASTM 4169.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, elbow, foot, ankle, and knee orthopedic procedures, including tendon repairs, ligament reconstructions, and capsular repairs.

Regulatory Classification

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.

Predicate Devices

• Stryker XCEL Anchor System (K023013)

Submission Summary (Full Text)

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JUN 1 4 2004

Endoscopy

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### Device Name

Classification Name:

Common and Usual Name: Proprietary Name:

Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3040, Class II Bioabsorbable Suture Anchor (MAI) Stryker XCEL Anchor System

### Predicate Device

Stryker XCEL Anchor System (#K023013), currently marketed by Stryker Endoscopy (San Jose, CA),

#### Summary

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

The line extension of the Stryker XCEL Anchor System is intended for use in providing a means for securing soft tissue to bone using suture. The line extension of the Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.

The line extension of the Stryker XCEL Anchor System will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 °. The device is biocompatible per ISO-10993-1 and G95-1. The line extension of the Stryker XCEL Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The line extension of the Stryker XCEL Anchor System is considered substantially equivalent to the Stryker XCEL Anchor System (#K023013).

Contact:

Date: May 6, 2004

Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2004

Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K041307

Trade/Device Name: Stryker XCEL Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: II Product Code: MAI Dated: May 6, 2004 Received: May 17, 2004

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosale) to tegains and the Medical Device Amendments, or to commerce price to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Acr (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of wastice, 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 If your device is classified (600 abs. of ols. Existing major regulations affecting your device can may oc subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be futur in the Out of I cants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issualled of a cademice complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must of any I cuttar statutes and regaranents and with the timited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 607), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Melissa Murphy

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manoling your article quivalence of your device to a legally premarket notification. The PDA midning of backander of ...
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 il you desire specific advice for your ac 110 %. 6.59. Also, please note the regulation entitled, provinces and Contact the Office of Complanes as (Set notification" (21CFR Part 807.97). You may obtain " Misoranding by release to premants. Iousliteans in the Act from the Division of Small other general information on your response at its toll-free number [phone] or Manufacturers, International and Golless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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# Indications for Use

510(k) Number (if known): K04130Z

Device Name: Stryker XCEL Anchor System

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

| Shoulder: | Elbow: |
|-------------------------------------------------------------|---------------------------------------|
| Bankart repair | Biceps tendon reattachment |
| SLAP lesion repair | Foot & Ankle: |
| Rotator cuff repair | Achilles tendon repair/reconstruction |
| Capsular shift repair | Lateral stabilization |
| Biceps tenodesis | Medial stabilization |
| Acromio-clavicular separation | |
| 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 System is intended for single-use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ....... (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) (Division Sign organ oral, Restorative, and Neurological Devices

510(k) Number_K041307_________________________________________________________________________________________________________________________________________________________