(195 days)
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Not Found
No
The device description and intended use focus on a mechanical suture anchor and do not mention any software, algorithms, or AI/ML capabilities.
Yes
The Harpoon® Suture Anchors are indicated for soft tissue reattachment and repair in various anatomical sites, which is a therapeutic function.
No
The provided text describes Harpoon® Suture Anchors as devices for soft tissue reattachment, which are used in orthopedic repair procedures. There is no mention of the device being used to diagnose conditions or gather physiological data.
No
The device description clearly describes a physical implantable device made of stainless steel with attached suture, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Harpoon® Suture Anchors are described as devices used for soft tissue reattachment to bone in various anatomical locations (shoulder, wrist, elbow, knee). They are physical implants used during surgical procedures.
- Lack of Diagnostic Activity: The description and intended use do not involve analyzing biological samples or providing diagnostic information. The device's function is purely mechanical and structural.
Therefore, the Harpoon® Suture Anchors fall under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Harpoon® Suture Anchors are indicated for use in soft tissue reattachment in the following indications:
-
- 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 .
- Wrist (Mini-Harpoon Suture Anchor only)
- Scapholunate Ligament Reconstruction
-
- Elbow (Harpoon and Mini-Harpoon Suture Anchors)
- Biceps Tendon Reattachment .
- Ulnar or Radial Collaterial 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 0
- Iliotibial Band Tenodesis Reconstruction ●
- Patellar Realignment and Repair ◆
- Patellar Ligament and Tendon Repair •
- Vastus Medialis Obliquus (VMO) Muscle Advancement t
Product codes (comma separated list FDA assigned to the subject device)
MBI
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. 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 polyester suture. This type of suture is found with other marketed suture anchors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder, Wrist, Elbow, 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)
Mechanical testing of these devices demonstrated its pull-out strength to be comparable to commercially available suture anchors with the same indicated use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
-
- 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 .
- Wrist (Mini-Harpoon Suture Anchor only)
- Scapholunate Ligament Reconstruction
-
- Elbow (Harpoon and Mini-Harpoon Suture Anchors)
- Biceps Tendon Reattachment .
- Ulnar or Radial Collaterial 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 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
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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
-
- (Mini-Harpoon Suture Anchor only) Nrist Scapholunate ligament reconstruction
-
- 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