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K Number
K965111
Device Name
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
Manufacturer
R. THOMAS GROTZ, M.D., INC.
Date Cleared
1997-02-18

(60 days)

Product Code
MBI
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below: Shoulder (Bankart repair, SLAP lesion repair, Acromioclavicular separation, Rotator cuff repair, Capsule shift \capsulolabral reconstruction, Biceps tenodesis, Deltoid repair), Elbow (Tennis elbow repair, Biceps tendon reattachment, Medial and lateral repairs), Ankle (Lateral instability, Medial instability, Achilles tendon repair/ reconstruction), Knee (Extra-capsular repairs and attachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament and joint capsule to tibia, joint capsule closure to the anterior proximal tibia; Extra-capsular reconstruction, ITB tenodesis; Patellar ligament and tendon avulsions repairs)
Device Description
The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment 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 soft tissue 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.
More Information

Not Found

Not Found

No
The device description focuses on a mechanical implant and surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

No
The device is described as an implant used for surgical reconstruction (mechanical attachment of soft tissue to bone) and not for treating or curing a disease or condition.

No

The device description clearly states its purpose as an implant for attaching soft tissue to bone using sutures in joint reconstruction procedures. It does not mention any function related to diagnosing medical conditions or diseases.

No

The device description clearly describes a physical implant made of 316L Stainless Steel, along with associated surgical tools (inserter, crimper). This is a hardware 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The Stabilizer Soft Tissue Anchor is a surgical implant made of stainless steel designed to attach soft tissue to bone during reconstructive procedures. It is a physical device used in vivo (within the body).
  • Intended Use: The intended use describes surgical procedures for repairing soft tissue and bone in various joints. This is a therapeutic and structural function, not a diagnostic one performed on a sample outside the body.

The description clearly indicates a surgical implant used directly in the body for structural support and repair, which is the opposite of an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below:

Shoulder

    1. Bankart repair
    1. SLAP lesion repair
    1. Acromioclavicular separation
    1. Rotator cuff repair
    1. Capsule shift / capsulolabral reconstruction
    1. Biceps tenodesis
    1. Deltoid repair

Elbow

    1. Tennis elbow repair
    1. Biceps tendon reattachment
    1. Medial and lateral repairs

Ankle

    1. Lateral instability
    1. Medial instability
    1. Achilles tendon repair/ reconstruction

Knee

    1. Extra-capsular repairs and attachment of:
    • medial collateral ligament
    • lateral collateral ligament
    • posterior oblique ligament and joint capsule to tibia
    • joint capsule closure to the anterior proximal tibia
    1. Extra-capsular reconstruction, ITB tenodesis
    1. Patellar ligament and tendon avulsions repairs

Product codes

Not Found

Device Description

The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment 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 soft tissue to the implanted anchor by using The anchor inserter (which spreads the stabilizer teeth of three sutures. 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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Elbow, Ankle, Knee

Indicated Patient Age Range

Not Found

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

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.

Mitek Superanchor™ 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

K965111

R. Thomas Grotz,

5100k) Premarket Notification Stabilizer™ Soft Tissue Anchor for Human Joints

- Confidential -

510(k) SUMMARY

Date Submitted:

FEB 18 1997

December 19, 1996

SUBMITTED BY:

R. Thomas Grotz, M.D. 530 Bush Street, 10th Floor San Francisco. California 94108 Telephone: (415) 398-2332 Fax: (415) 398-2614

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

PREDICATE DEVICE

Mitek Superanchor™ manufactured by Mitek Surgical Products, Inc.

DEVICE DESCRIPTION

The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment 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 soft tissue to the implanted anchor by using The anchor inserter (which spreads the stabilizer teeth of three sutures. 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 intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below:

Shoulder

    1. Bankart repair
    1. SLAP lesion repair
    1. Acromioclavicular separation
    1. Rotator cuff repair

Elbow

    1. Tennis elbow repair
    1. Biceps tendon reattachment
    1. Medial and lateral repairs

1

R. Thomas Grotz, M.D.

  • Confidential -

510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for Human Joints

Shoulder (continued)

    1. Capsule shift \capsulolabral
  • reconstruction
    1. Biceps tenodesis
    1. Deltoid repair

Ankle

    1. Lateral instability
    1. Medial instability
    1. Achilles tendon repair/ reconstruction

Knee

    1. Extra-capsular repairs and attachment of:
    • medial collateral ligament
    • lateral collateral ligament
    • posterior oblique ligament and joint capsule to tibia
    • joint capsule closure to the anterior proximal tibia
    1. Extra-capsular reconstruction, ITB tenodesis
    1. Patellar ligament and tendon avulsions repairs

CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLI-CATIONS

    1. 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.
    1. Warnings
    • 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 appropriate sized anchor and suture are being used and that the appropriate number of anchors are present to support the 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."
    • To assure proper bone cutting 2.2 The drill is stainless steel. 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.

2

R. Thomas Grotz, M.D.

510(k) Premarket Notification Stabilizer™ Soft Tissue Anchor for Human Joints

  • Confidential -

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. 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.

    1. Complications
      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.

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.