ANSPACH SUTURE ANCHOR

K981688 · The Anspach Effort, Inc. · MBI · Jul 13, 1998 · Orthopedic

Device Facts

• Record ID: K981688
• Device Name: ANSPACH SUTURE ANCHOR
• Applicant: The Anspach Effort, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixation of soft tissue to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. Specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.

Device Story

Anspach Suture Anchor is a surgical implant designed for soft tissue-to-bone fixation. Used by orthopedic surgeons in clinical settings to reattach tendons or ligaments to bone. Device provides mechanical anchoring point for sutures, facilitating tissue healing. Operates via physical implantation into bone; no electronic or software components. Benefits include secure tissue fixation during orthopedic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical suture anchor for orthopedic fixation. Materials and specific dimensions not detailed in provided text. Non-electronic, non-software device.

Indications for Use

Indicated for fixation of soft tissue to bone in various orthopedic applications including pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella, and bones of hand and foot. Contraindicated for use in the spine or for repair of anterior or posterior cruciate ligaments.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TUL 1 3 1998

William E. Anspach, III, M.D. · Vice President, R&D Regulatory The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K981688 Anspach Suture Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 10, 1998 Received: May 11, 1998

Dear Dr. Anspach:

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 The general controls provisions of the Act 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 Requlation (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 In addition, FDA may publish further announcements action. 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.

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Page 2 - William E. Anspach, III, M.D.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

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 of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Anspach Suture Anchor

Indications For Use:

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Fixation of soft tissue to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot.

Specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K981688 |

| Prescription Use | X | OR | Over-The-Counter Use | / |
|----------------------|---|----|-----------------------|---|
| (Per 21 CFR 801.109) | | | (Optional Form 1-2-9) | |