K Number
K012334
Device Name
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
Date Cleared
2001-09-19

(57 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.
Device Description
The device description of the Contour Meniscus Arrow™ is as follows. - Composed of poly-L/D-polylactide copolymer - Length 10, 13 and 16mm - Diameter 1.1mm
More Information

Not Found

No
The summary describes a physical implantable device for meniscus repair and does not mention any software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is described as being used for "arthroscopic fixation of longitudinal vertical meniscus lesions" which is a treatment for a medical condition.

No
Explanation: The device is intended for arthroscopic fixation of meniscus lesions, which is a therapeutic intervention, not a diagnostic one.

No

The device description explicitly states it is composed of poly-L/D-polylactide copolymer and has physical dimensions (length and diameter), indicating it is a physical implant, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the arthroscopic fixation of meniscus lesions. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
  • Device Description: The device is a physical implant (an arrow) made of a biodegradable material. This is consistent with a surgical device, not an IVD which would typically involve reagents, instruments for analyzing samples, or software for interpreting test results.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Contour Meniscus Arrow™ is a therapeutic device used to repair a physical injury.

N/A

Intended Use / Indications for Use

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

Product codes

MAI

Device Description

The device description of the Contour Meniscus Arrow™ is as follows.

  • Composed of poly-L/D-polylactide copolymer
  • Length 10, 13 and 16mm
  • Diameter 1.1mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

meniscus

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K955768, K993453

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

K012334

1

510(k) Summary Bionx Implants Inc. Meniscus Arrow™

Submitter's Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422

Contacts:

Gerard S. Carlozzi President and Chief Executive Officer (215) 643-5000 Phone: Facsimile: (215) 653-0984

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629

July 9th, 2001 Date prepared:

Name of the device:

A.Trade or Proprietary Name:Contour Meniscus Arrow™
B.Common Name:Bioabsorbable Meniscus Arrow System
C.Classification Name:Biodegradable soft tissue fixation fastener
D.Device Product Code:MAI

Predicate Devices:

Bionx Implants Inc. Biofix® Biodegradable Meniscus Arrow System (K955768) Bionx Implants Inc. Meniscus ArrowTM (K993453)

1

Intended Use:

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The principles of operation is completely identical with the predicate device.

Device Description:

The device description of the Contour Meniscus Arrow™ is as follows.

  • Composed of poly-L/D-polylactide copolymer ।
  • Length 10, 13 and 16mm -
  • । Diameter 1.1mm

The dimensions and shape subtstantially equivalent to the Biofix® Biodegradable Meniscus Arrow System (K955768) and Meniscus Arrow (K993453).

Substantial Equivalence:

The Contour Meniscus Arrow™ has the following similarities to the cleared Biofix® Biodegradable Meniscus Arrow System (K955768) and Meniscus Arrow (K993453):

  • has the same indicated use
  • uses the same operating principle -
  • incorporates the same basic design
  • is manufactured by same machinery -
  • is packaged and sterilized using the same materials and processes -
  • has the same shelf life

In summary, the Contour Meniscus Arrow™ described is substantially equivalent to the predicate device. This change of raw material and minor modifications of the design does not raise any new problems concerning safety or efficacy of the device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Bionx Implants, Inc. c/o Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants. Ltd. Hermiankatu 6-8 L Tampere, Finland

Re: K012334/S001

Trade Name: Contour Meniscus Arrow Regulation Number: Unclassified Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: Unclassified Product Code: MAI Dated: August 28, 2001 Received: August 30, 2001

Dear Mrs. Annala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the charenean and 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, oond 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 If your device 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 r hat 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 or unry 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 OFF Part 8077, laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Ms. Tuija Annala

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Walker, us

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

4

INDICATIONS FOR USE

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Contour Meniscus Arrow™M

Indications for Use:

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use__\r

(Per 21 CFR 801.109)

Over-The-Counter Use_ OR

SL

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012334