K Number
K041307
Device Name
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
Manufacturer
Date Cleared
2004-06-14

(28 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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 Elbow: Biceps tendon reattachment Foot & Ankle: Achilles tendon repair/reconstruction Lateral stabilization Medial stabilization The Stryker XCEL Anchor System is intended for single-use only.
Device Description
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.
More Information

Not Found

No
The document describes a mechanical anchor system and explicitly states "Not Found" for mentions of AI, DNN, or ML.

No
The device is an anchor system used to secure soft tissue to bone during surgical repairs, which is a restorative rather than a therapeutic function.

No

The device description and intended use indicate that the Stryker XCEL Anchor System is a surgical anchor used to secure soft tissue to bone during repair procedures, which is a therapeutic function, not diagnostic.

No

The device description explicitly states it consists of a physical anchor made of PLLA, surgical suture, and a disposable inserter, which are all hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical device used to secure soft tissue to bone in various anatomical locations (shoulder, knee, elbow, foot & ankle). This is a therapeutic and structural function, not a diagnostic one.
  • Device Description: The device is described as an anchor made of PLLA with surgical suture, pre-assembled on an inserter. This is consistent with a surgical implant and delivery system.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stryker XCEL Anchor System does not fit this description.

N/A

Intended Use / Indications for 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.

Product codes

MAI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Elbow, Foot & Ankle, Knee

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject device was shown to have substantially equivalent performance when compared to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K023013

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is in lowercase letters, and the letters are closely spaced together. Above the word "stryker" is a small, illegible marking. The overall impression is of a company logo or brand name.

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 (408) 754-2148

1

Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "Department of Health & Human Services - USA" arranged around the perimeter. In the center of the seal is the department's logo, which features a stylized human figure with three arms raised upwards.

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.

2

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 (800) 638-2041 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

3

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 repairBiceps tendon reattachment
SLAP lesion repairFoot & Ankle:
Rotator cuff repairAchilles tendon repair/reconstruction
Capsular shift repairLateral stabilization
Biceps tenodesisMedial 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_________________________________________________________________________________________________________________________________________________________