LogoFDA 510(k) Search
K Number
K973775
Device Name
HARPOON SUTURE ANCHORS
Manufacturer
BIOMET, INC.
Date Cleared
1998-04-16

(195 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
K012469,K012503,K012572,K012872,K042460,K071520,K071816,K080447
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Harpoon® Suture Anchors are indicated for use in soft tissue reattachment in the following indications:

    1. Shoulder (Harpoon and Mini-Harpoon Suture Anchors)
    • Bankart Repair
    • SLAP Lesion Repair
    • Acromio-Clavicular Separation Repair
    • Rotator Cuff Repair
    • Capsule Repair and Capsulolabral Reconstruction
    • Biceps Tenodesis
    • Deltoid Repair
    1. Wrist (Mini-Harpoon Suture Anchor only)
    • Scapholunate Ligament Reconstruction
    1. Elbow (Harpoon and Mini-Harpoon Suture Anchors)
    • Biceps Tendon Reattachment
    • Ulnar or Radial Collaterial Ligament Reconstruction
    1. Knee (Harpoon and Mini-Harpoon Suture Anchors) Extra-Capsular Repair:
    • Medial Collateral Ligament Repair
    • Lateral Collateral Ligament Repair
    • Posterior Oblique Ligament Repair
    • Joint Capsule Closure
    • Iliotibial Band Tenodesis Reconstruction
    • Patellar Realignment and Repair
    • Patellar Ligament and Tendon Repair
    • Vastus Medialis Obliquus (VMO) Muscle Advancement
Device Description

The suture anchor with suture attached is pushed into the bone for anchorage of the soft tissue to the bone. The anchor is designed with a angled point and can be tapped directly into bone without a pre-drilled bone hole. The collar of the device is divided into four proximally open fins which provide resistance to pull-out forces applied to the device. The Harpoon® Suture Anchors are manufactured from 316 IVM stainless steel conforming to ASTM F-138. The suture anchor is provided pre-threaded with a polyester suture.

AI/ML Overview

The provided text describes the Harpoon® Suture Anchors and their indications for use, as well as the FDA's clearance (K973775) acknowledging their substantial equivalence to predicate devices. However, the document does not contain information regarding a specific study with acceptance criteria and reported device performance in the format requested.

The text states:
"Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use."

This implies that some form of "mechanical testing" was performed to compare the Harpoon® Suture Anchors to existing devices, and that the results met an implicit acceptance criterion of "comparability" for pull-out strength. However, the details of this testing, including the specific quantitative acceptance criteria, the methodology, sample size, or the explicitly reported performance values, are not provided.

Therefore, an answer in the requested format cannot be fully generated from the provided text.

Here's an explanation of what is and isn't available:

  1. A table of acceptance criteria and the reported device performance:

    • Acceptance Criteria: Not explicitly stated in quantitative terms. The text mentions "comparable to commercially available suture anchors with the same indicated use" for pull-out strength.
    • Reported Device Performance: Not numerically reported. The text only states that it was "comparable."

  2. Sample size used for the test set and the data provenance: Not mentioned.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was mechanical testing, not a human reader study requiring expert ground truth in the context of diagnostic performance.

  4. Adjudication method for the test set: Not applicable for mechanical testing.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a medical device (suture anchor), not an AI-assisted diagnostic tool.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the direct measurement of pull-out strength under controlled experimental conditions, often against established engineering standards or direct comparison to predicate devices, but the specifics are not detailed.

  8. The sample size for the training set: Not applicable, as this refers to training a model, not performing mechanical device testing.

  9. How the ground truth for the training set was established: Not applicable.

Conclusion based on the provided text:

The document states that "Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use." This serves as the implicit acceptance criteria and the study finding for the device. However, the specific quantitative details of this testing are not provided in the submitted text.

{0}------------------------------------------------

APR 16 1998

Summary of Safety and Effectiveness

9737-

The Harpoon® Suture Anchors are indicated for use in soft tissue reattachment in the following indications:

    1. Shoulder (Harpoon and Mini-Harpoon Suture Anchors)
    • Bankart Repair ●
    • SLAP Lesion Repair .
    • Acromio-Clavicular Separation Repair �
    • Rotator Cuff Repair .
    • Capsule Repair and Capsulolabral Reconstruction .
    • Biceps Tenodesis .
    • Deltoid Repair .
  1. Wrist (Mini-Harpoon Suture Anchor only)
  • Scapholunate Ligament Reconstruction
    1. Elbow (Harpoon and Mini-Harpoon Suture Anchors)
    • Biceps Tendon Reattachment .
      • Ulnar or Radial Collaterial Ligament Reconstruction .
    1. Knee (Harpoon and Mini-Harpoon Suture Anchors) Extra-Capsular Repair:
    • Medial Collateral Ligament Repair .
    • Lateral Collateral Ligament Repair .
    • Posterior Oblique Ligament Repair ●
    • Joint Capsule Closure 0
    • Iliotibial Band Tenodesis Reconstruction ●
    • Patellar Realignment and Repair ◆
    • Patellar Ligament and Tendon Repair •
    • Vastus Medialis Obliquus (VMO) Muscle Advancement t

The suture anchor with suture attached is pushed into the bone for anchorage of the soft tissue to the bone. The anchor is designed with a angled point and can be tapped directly into bone without a pre-drilled bone hole. The collar of the device is divided into four proximally open fins which provide resistance to pull-out forces applied to the device.

The Harpoon® Suture Anchors are manufactured from 316 IVM stainless steel conforming to ASTM F-138. This metal is commonly used in implants and its safety established after many years of use. The suture anchor is provided pre-threaded with a

{1}------------------------------------------------

polyester suture. This type of suture is found with other marketed suture anchors.

Metallic suture anchors are currently available to attach soft tissue to bone in the shoulder, wrist, hand, ankle, foot, elbow, and knee. Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use.

  • Manufacturer: Biomet, Inc. Airport Industrial Park P.O. box 587 Warsaw, IN 46581-0587
  • Distributor: Arthrotek, Inc. Ontario, CA 91761

{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 stylized eagle with three lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 1998

Ms. Mary L. Verstynen Clinical Research Manager Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K973775 Trade Name: Harpoon and Mini Harpoon Suture Anchors Regulatory Class: II Product Code: MBI Dated: January 15, 1998 Received: January 16, 1998

Dear Ms. Verstynen:

We have reviewed your Section 510(k) 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 been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A...... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Mary L. Verstynen

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Ar Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

、・

Page __ 1_ of 1

510(k) NUMBER (IF KNOWN): K973775

DEVICE NAME: Harpoon Suture Anchor

INDICATIONS FOR USE:

  • Shoulder (Harpoon and Mini-Harpoon Suture Anchors) 1 ) Bankart repair, SLAP lesion repair, -acromio-clavicular separation repair, rototar cuff repair, capsule repair and capsulolabral reconstruction, Biceps tendosis, deltoid rep
    1. (Mini-Harpoon Suture Anchor only) Nrist Scapholunate ligament reconstruction
    1. Elbow (Harpoon and Mini-Harpoon Suture Anchors) Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction

Knee (Harpoon and Mini-Harpoon Suture Anchors) ್ ( ) Extra-Capsular Repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction , patellar realignment and repair, patellar ligament and tendon repair, vastus medialis obliquus VMO) muscle advancement

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Stephen Rhodes

(Division Sign-Off Division of General Restorative Devic 510(k) Number

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.