K Number
K022079
Device Name
SHORT AND LONG SOFT TISSUE ATTACHMENT
Manufacturer
Date Cleared
2002-09-24

(90 days)

Product Code
Regulation Number
888.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for the use of the Short and Long Soft Tlssue Attachment Sleeves include: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Revision where other devices or treatments have failed 4. Correction of functional deformity 5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods The sleeves can be used for oncology applications. The sleeves are designed for use with the Biomet Mosaic™ Humeral System (K020045), to provide the option for soft tissue stabilization and attachment. The Biomet Mosaic™ Humeral System (K020045) is for use with bone cernent.
Device Description
This particular design utilizes a taper junction between the sleeve and the segment component of the Biomet Proximal Humeral Replacement System (K020045). For secure placement, the sleeve has a larger proximal taper junction. Because the soft tissue will naturally be pulling proximally, if the taper junction does move, the soft tissue will only tighten the taper. There are two sizes that vary only in length and suture hole availability. The short sleeve has 4 suture holes available and the holes are arranged perpendicular to the axis of the segment. The long sleeve has 5 suture holes that are arranged perpendicular to the axis of the segment and 4 suture holes placed parallel to the axis of the segment. Both sleeves have the same outside and inside diameters and inside mating taper. The sleeves are designed for use in conjunction with the Biomet Modular Proximal Humeral Replacement System (K020045), now called the Mosaic™ Humeral System to provide the option for soft tissue stabilization and attachment to the prosthetic device
More Information

Not Found

No
The document describes a mechanical implant component (sleeves for soft tissue attachment) and does not mention any software, algorithms, or data processing that would involve AI or ML.

Yes
The device is described as an attachment sleeve used with a humeral system for conditions like osteoarthritis and rheumatoid arthritis, which are treated by medical means.

No

The device description indicates that the Short and Long Soft Tissue Attachment Sleeves are designed for soft tissue stabilization and attachment to a prosthetic device (Biomet Mosaic™ Humeral System), not for identifying or investigating diseases or conditions. Its intended uses involve treatment for conditions like degenerative joint disease or fractures, or for revision, rather than diagnosis.

No

The device description clearly describes physical components (sleeves with taper junctions and suture holes) designed for surgical implantation and attachment to a prosthetic device. This is a hardware medical device, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant designed to be used within the human body to treat various joint conditions and fractures. It is used in conjunction with a humeral replacement system.
  • Device Description: The description details a physical component (a sleeve) that attaches to a prosthetic device and provides points for soft tissue attachment.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.

IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.

N/A

Intended Use / Indications for Use

The indications for the use of the Short and Long Soft Tlssue Attachment Sleeves include:

  • include: necrosis
    1. Rheumatoid arthritis
    1. Revision where other devices or treatments have failed
    1. Correction of functional deformity
    1. Treatment of acute fracture of the humeral head unmanageable using other treatment methods

The sleeves can be used for oncology applications.

The sleeves are designed for use with the Biomet Mosaic™ Humeral System (K020045), to provide the option for soft tissue stabilization and attachment.

The Biomet Mosaic™ Humeral System (K020045) is for use with bone cernent.

Product codes (comma separated list FDA assigned to the subject device)

KWT

Device Description

This particular design utilizes a taper junction between the sleeve and the segment component of the Biomet Proximal Humeral Replacement System (K020045). For secure placement, the sleeve has a larger proximal taper junction. Because the soft tissue will naturally be pulling proximally, if the taper junction does move, the soft tissue will only tighten the taper.

There are two sizes that vary only in length and suture hole availability. The short sleeve has 4 suture holes available and the holes are arranged perpendicular to the axis of the segment. The long sleeve has 5 suture holes that are arranged perpendicular to the axis of the segment and 4 suture holes placed parallel to the axis of the segment. Both sleeves have the same outside and inside diameters and inside mating taper.

The sleeves are designed for use in conjunction with the Biomet Modular Proximal Humeral Replacement System (K020045), now called the Mosaic™ Humeral System to provide the option for soft tissue stabilization and attachment to the prosthetic device

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

humeral head

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)

Non-Clinical Testing: Mechanical testing with Engineering Justifications determined that the Short and Long Soft Tissue Attachment Sleeve components presented no new risks and were therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

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.

K913282, K020045

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

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

0

022079

SEP 2 4 2002

Summary of Safety and Effectiveness

| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|-------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | Short and Long Soft Tissue Attachment Sleeve |
| Common Name: | Short and Long Soft Tissue Attachment Sleeve |
| Classification Name: | Prosthesis, shoulder non-constrained, metal / polymer
cemented (21 CFR 888.3650) |

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

    1. LIMA RPS Shoulder (K913282)
    1. Biomet Modular Proximal Humeral Replacement System (K020045), now known as the Mosaic™ Humeral System

Device Description: This particular design utilizes a taper junction between the sleeve and the segment component of the Biomet Proximal Humeral Replacement System (K020045). For secure placement, the sleeve has a larger proximal taper junction. Because the soft tissue will naturally be pulling proximally, if the taper junction does move, the soft tissue will only tighten the taper.

There are two sizes that vary only in length and suture hole availability. The short sleeve has 4 suture holes available and the holes are arranged perpendicular to the axis of the segment. The long sleeve has 5 suture holes that are arranged perpendicular to the axis of the segment and 4 suture holes placed parallel to the axis of the segment. Both sleeves have the same outside and inside diameters and inside mating taper.

The sleeves are designed for use in conjunction with the Biomet Modular Proximal Humeral Replacement System (K020045), now called the Mosaic™ Humeral System to provide the option for soft tissue stabilization and attachment to the prosthetic device

1

022079

0.2/2

Indications:

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
    1. Rheumatoid arthritis
    1. Revision where other devices or treatments have failed
    1. Correction of functional deformity
    1. Treatment of acute fracture of the humeral head unmanageable using other treatment methods.

The sleeves can be used for oncology applications.

The sleeves are designed for use with the Biomet Modular Proximal Humeral Replacement System (K020045), now called the Mosaic™ Humeral System to provide the option for soft tissue stabilization and attachment.

The Biomet Proximal Humeral Replacement System (K020045) is for use with bone cement.

| Summary of Technologies: | The Short and Long Soft Tissue Attachment
Sleeve components (materials, design, sizes
and indications) are similar or identical to the
predicate devices. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing: | Mechanical testing with Engineering
Justifications determined that the Short and
Long Soft Tissue Attachment Sleeve
components presented no new risks and were
therefore, substantially equivalent to the
predicate device. |
| Clinical Testing: | No clinical testing was provided as a basis for
substantial equivalence. |

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FP 2 4 2002

Ms. Kacy Arnold, RN, MBA Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0578

Re: K022079

Trade/Device Name: Short and Long Soft Tissue Attachment Sleeves Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT Dated: June 14, 2002 Received: June 26, 2002

Dear Ms. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Ms. Kacy Arnold, RN, MBA

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Milliman

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510 (k) Number (if known):

K 022079

Device Name: Short and Long Soft Tissue Attachment Sleeves

Indications for Use:

The indications for the use of the Short and Long Soft Tlssue Attachment Sleeves include:

  • include: necrosis
    1. Rheumatoid arthritis
    1. Revision where other devices or treatments have failed
    1. Correction of functional deformity
    1. Treatment of acute fracture of the humeral head unmanageable using other treatment methods

The sleeves can be used for oncology applications.

The sleeves are designed for use with the Biomet Mosaic™ Humeral System (K020045), to provide the option for soft tissue stabilization and attachment.

The Biomet Mosaic™ Humeral System (K020045) is for use with bone cernent.

Mark N. Millerson

i Pestorative ( %: and Neurological Boulees

510(k) Number K022074

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_ (Optional Format 1-2-96)