(58 days)
The Stabilizer Soft Tissue Anchor is a titanium alloy implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
The Stabilizer Soft Tissue Anchor is a titanium alloy (Ti 6A1-4V ELI Alloy for Surgical Implant Applications per ASTM F136-92) implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. The Stabilizer is 8 mm in diameter. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site if required during the implantation procedure.
The provided 510(k) Premarket Notification for the Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction does not contain information about acceptance criteria or a study proving that the device meets such criteria.
This 510(k) submission, dated 1999, focuses on demonstrating substantial equivalence to existing predicate devices based on design, material, and function. The 510(k) summary provides:
- Device Description: Details on the titanium alloy implant, its diameter, and the installation procedure.
- Indications for Use: Specifies its application in ACL repair or reconstruction.
- Contraindications, Warnings, Precautions, and Complications: Important safety information.
- Comparison of Technological Characteristics: A statement asserting substantial equivalence to predicate devices.
- FDA Response Letter: Confirming substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The document does not describe performance targets, test results, sample sizes, ground truth establishment, or expert involvement in a study designed to meet specific performance criteria.
In summary, the provided document does not contain the information necessary to fulfill your request, as it pertains to a regulatory submission demonstrating substantial equivalence rather than a detailed performance study with defined acceptance criteria.
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JAN 2 1 1999
510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
R. Thomas Grotz, M.D.
- Confidential -
510(k) SUMMARY
SUBMITTED BY:
R. Thomas Grotz, M.D. 530 Bush Street. 10th Floor San Francisco, California 94108 Telephone: (415) 398-2332 Fax: (415) 398-2614
Date Submitted: November 17, 1998
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name:
Common/Usual Name: Proprietary Name:
Fastener, fixation, nondegradable, soft tissue Soft Tissue Anchor Stabilizer™ Soft Tissue Anchor
PREDICATE DEVICES
Stabilizer Soft Tissue Anchors cleared under 510(k)'s 964927 and 973031, and Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc. [510(k) K92670].
DEVICE DESCRIPTION
The Stabilizer Soft Tissue Anchor is a titanium alloy (Ti 6A1-4V ELI Alloy for Surgical Implant Applications per ASTM F136-92) implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. The Stabilizer is 8 mm in diameter. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site if required during the implantation procedure.
INDICATIONS FOR USE:
The Stabilizer Soft Tissue Anchor is a titanium alloy implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction.
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- Confidential -
Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLI-CATIONS
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- Contraindications
The Stabilizer Soft Tissue Anchor is contraindicated in the presence of pathological conditions such as severe osteopenia, cystic degeneration, or comminution of bone which would compromise fixation. The Stabilizer should not be used in compromised bone or in the presence of pathological soft tissue conditions which would compromise fixation. It should also not be used in the presence of pathophysiological conditions such as infection, osteonecrosis, or bone disease. The product should not be used in patients with known allergies to titanium.
- Contraindications
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- Warnings
- 2.1 The Stabilizer Soft Tissue Anchor is intended to assist in the Each case should be carefully fixation of soft tissue to bone. analyzed to assure that the anchor and suture are appropriate to support the repair/reconstruction. Excessive tension on the suture or anchor may result in suture breakage or implant pullout from the bone. In some cases, revisions may require explant of the bone anchor.
- The drill is stainless steel. To assure proper bone cutting 2.2 characteristics, the drill should be replaced after every 10 uses. If the drill should break during use, remnants should be removed from the surgical site prior to proceeding.
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- Precautions
The Stabilizer Soft Tissue Anchor is intended for use by surgeons familiar with soft tissue and bone attachment techniques. The patient must be cautioned against early weightbearing and/or premature ambulation as this could lead to loosening or failure of the implant or suture attachments. Standard postoperative practices for the treatment and rehabilitation of repaired joints must be followed.
- Complications র্বা
Potential complications with the The Stabilizer Soft Tissue Anchor include, but are not limited to, the following: infection, osteomyelitis, suture breakage, implant breakage, implant pull-out, reoperation, revision or explant.
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510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
R. Thomas Grotz, M.D.
- Confidential -
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The product design, material of construction, and function as a soft tissue anchor is substantially equivalent to the FDA cleared predicate devices.
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Public Health Service
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JAN 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Grotz, M.D R. 530 Bush Street, 10th Floor San Francisco, California 94108
Re: K984200 8mm Stabilizer Soft Tissue Anchor (Ti-alloy) Trade Name: Regulatory Class: II Product Codes: MBI and HWC November 17, 1998 Dated: November 24, 1998 Received:
Dear Dr. Grotz:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 requlation may result in requlatory 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.
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Page 2 - R. Thomas Grotz, 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 ene regulation Chercrea) Hisbiananig by Coronos eral 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,
Celia M. Witten, Ph.D., M.D.
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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R. Thomas Grotz, M.D.
- Confidential -
Page 1 of 1
510(k) Number (if known): Not Known K 7843,00
Device Name: Stabilizer™ Soft Tissue Anchor
The Stabilizer Soft Tissue Anchor is a titanium alloy Indications for Use: implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair Stabilizer instruments must be used to install the or reconstruction. Stabilizer Soft Tissue Anchor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f Device Evaluation (SDE)
(Division Sign-Off)
Division of General Restorative Devices K984206
510(k) Number
Prescription Use (PER 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
N/A