(81 days)
K964297, 92670
Not Found
No
The summary describes a mechanical implant and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is described as an implant used for ACL repair or reconstruction, which is a therapeutic intervention.
No
The device is an implant used for repair or reconstruction, not for diagnosis. It is an attachment means for soft tissue and bone, and the description focuses on its implantation and function within the body.
No
The device description clearly states it is a stainless steel implant and requires instruments for installation, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Stabilizer Soft Tissue Anchor is a surgical implant made of stainless steel. It is intended to be implanted directly into the bone to attach soft tissue during ACL repair or reconstruction.
- Intended Use: The intended use is for surgical repair/reconstruction, not for testing biological samples.
The device is a physical implant used within the body during a surgical procedure, which is the opposite of an in vitro diagnostic device that performs tests outside the body.
N/A
Intended Use / Indications for Use
The Stabilizer Soft Tissue Anchor is a stainless steel implant intended for use 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use 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.
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 up to three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures, as may be required, to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole. If sutures are not used, use of the crimper is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone in Anterior Cruciate Ligament (ACL)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K964297, 92670
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
§ 890.3490 Truncal orthosis.
(a)
Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
R. Thomas Grotz, M.D.
510(k) Premarket Notification 6 mm Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
- Confidential -
1973031 510(k) SUMMARY
SUBMITTED BY:
NOV - 3 1997
R. Thomas Grotz, M.D. 530 Bush Street, 10th Floor San Francisco, California 94108 Telephone: (415) 398-2332 (415) 398-2614 Fax:
Date Submitted: August 13, 1997
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Fastener, fixation, nondegradable, soft
tissue |
|----------------------|---------------------------------------------------|
| Common/Usual Name: | Soft Tissue Anchor |
| Proprietary Name: | Stabilizer™ Soft Tissue Anchor, 6 mm |
PREDICATE DEVICES
Stabilizer Soft Tissue Anchor, 8mm, cleared February 7, 1997 under 510(k) K964297 and the Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc [510(k) 92670].
DEVICE DESCRIPTION
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use 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.
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 up to three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures, as may be required, to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole. If sutures are not used, use of the crimper is optional.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R. Thomas Grotz, M.D. 530 Bush Street 10th Floor San Francisco, California 94108
NOV - 3 1997
Re: K973031 6 mm Stabilizer™ Soft Tissue Anchor Trade Name: Requlatory Class: II Product Codes: MBI and HWC Dated: August 13, 1997 Received: August 14, 1997
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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 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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This letter will allow you to beqin 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 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,
Celia M. Witten, Ph.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
3
510(k) Premarket Notification ... ...... 6 mm Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
- Confidential -
Page 1 of 1
510(k) Number (if known): Not Known
Device Name: Stabilizer™ Soft Tissue Anchor, 6 mm
The Stabilizer Soft Tissue Anchor is a stainless steel Indications for Use: implant intended for use 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to coee
Division Sign-Off) Division of General Restorative Devices $10(k) Number.
Prescription Use (PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)