(60 days)
Mitek Ligament Anchor
Not Found
No
The description focuses on a mechanical implant and surgical instruments, with no mention of AI/ML capabilities or data processing.
Yes
The device is a permanent implant used in ACL repair/reconstruction to facilitate the body's natural healing process by reattaching soft tissue to bone, which aligns with the definition of a therapeutic device.
No
The provided text explicitly states that the device is an implant for soft tissue and bone attachment in ACL repair or reconstruction, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a 316L stainless steel implant and includes descriptions of physical instruments used for its installation. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The Stabilizer Soft Tissue Anchor is a surgical implant used to physically attach soft tissue and bone during ACL repair or reconstruction. It is a mechanical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is for physical attachment of tissue and bone, not for analyzing biological samples to provide diagnostic information.
The description clearly indicates a surgical implant and associated instruments used directly on the patient during surgery, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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.
Product codes
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Device Description
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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.
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 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissue and bone in Anterior Cruciate Ligament (ACL)
Indicated Patient Age Range
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Intended User / Care Setting
surgeons familiar with soft tissue and bone attachment techniques
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc.
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
R. Thomas Grotz, M.D.
510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
FEB -7 1997
- Confidential -
510(k) SUMMARY
SUBMITTED BY:
R. Thomas Grotz, M.D. 530 Bush Street, 10th Floor San Francisco, California 94108 Telephone: (415) 398-2332 (415) 398-2614 Fax:
Date Submitted: December 6, 1996
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Fastener, fixation, nondegradable, soft Classification Name: tissue Soft Tissue Anchor Common/Usual Name: Stabilizer™ Soft Tissue Anchor, 8 mm Proprietary Name:
PREDICATE DEVICE
Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc.
DEVICE DESCRIPTION
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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.
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 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 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.
INDICATIONS FOR USE:
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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.
1
510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction
- Confidential -
1 7 6 4 9 2
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 stainless steel.
- Contraindications
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Warnings 2.
- The Stabilizer Soft Tissue Anchor is intended to assist in the 2.1 fixation of soft tissue to bone. Each case should be carefully 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 4.
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.
2
R. Thomas Grotz, M.D.
510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor
for ACL RepairReconstruction
- Confidential -
1904-727
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 device.