K Number
K032507
Device Name
INTERLOK BIO-MODULAR HUMERAL STEMS
Manufacturer
Date Cleared
2003-09-05

(22 days)

Product Code
Regulation Number
888.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate Non-coated (Interlok®) devices are indicated for cemented application only.
Device Description
Manufactured from Ti-6Al-4V Bi-planer tapered stem 30 grit blested Interlok® surface finish Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment hole Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.
More Information

Not Found

No
The summary describes a shoulder implant made of Ti-6Al-4V with specific design features and sizes. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The description focuses solely on the physical characteristics and intended use of the implant.

Yes
The device is indicated for treating various medical conditions such as degenerative joint disease, rheumatoid arthritis, fractures, and functional deformities.

No
The device description and intended use indicate it is an orthopedic implant for joint replacement and fracture repair, not a tool for diagnosing medical conditions.

No

The device description clearly indicates it is a physical implant manufactured from Ti-6Al-4V with specific dimensions and features, which is hardware.

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

Here's why:

  • Intended Use: The intended use clearly describes a device for surgical implantation to treat various conditions of the shoulder joint (osteoarthritis, rheumatoid arthritis, fractures, etc.). This is a therapeutic device, not a diagnostic one.
  • Device Description: The description details the physical characteristics of a shoulder implant (material, shape, sizes, surface finish). This is consistent with a surgical implant.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

Therefore, this device falls under the category of a surgical implant and not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

    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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
    1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Non-coated (Interlok®) devices are indicated for cemented application only.

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

KWT, KWS, HSD

Device Description

  • Manufactured from Ti-6Al-4V
  • Bi-planer tapered stem
  • 30 grit blested Interlok® surface finish
  • Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment . hole
  • Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Humeral

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)

Clinical/Non-Clinical Testing: None provided

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.

K992119

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

SEP - 5 2003

510(k) Summary

| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|--------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres
Senior Regulatory Specialist
Telephone: (219) 267-6639
Fax: (219) 372-1683 |

Proprietary Name: Interiok® Blo-Modular® Shoulder Humeral Stems

Common Name: Shoulder Humeral Stem

Classification Name:

    1. Prosthesis, Shoulder, non-constrained, Cemented (21 CFR Section 888.3650)
    1. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3660)
    1. Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented (21 CFR Section 888.3690)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Devices are a modification of The Bio-Modular® Shoulder System cleared in 510(k) K992119.

Device Description:

  • ◆ Manufactured from Ti-6Al-4V
  • . Bi-planer tapered stem
  • 30 grit blested Interlok® surface finish ●
  • Sizes 6mm x 70mm and 7-15mm x115mm, in 2mm increments, with fin, collar and alignment . hole
  • . Sizes 6-15mm x 70mm, modified devices with no collar, fin or alignment hole.

Intended Use:

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
    1. Rheumatoid arthritis
  • Revision where other devices or treatments have failed 3)
    1. Correction of functional deformity
  • Fractures of the proximal humerus, where other methods of treatment are deemed inadequate 5)
  • Difficult clinical management problems, Including cuff arthropathy, where other methods of 6) treatment may not be suitable or may be Inadequate

Non-coated (Interlok®) devices are indicated for cemented application only.

Summary of Technologies: The design, materials and processing of the device are similar to the predicate device.

Clinical/Non-Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

1

SEP - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K032507 Trade/Device Name: Interlok® Bio-Modular® Humeral Stems Regulation Number: 21 CFR 888.3650, 888.3660, 888.3690 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis, Shoulder joint metal/polymer semi-constrained cemented prosthesis, Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: KWT, KWS, HSD Dated: August 13, 2003 Received: August 14, 2003

Dear Ms. Beres:

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.

2

Page 2- Ms. Patricia Sandborn Beres

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Sincerely yours,

Mark N. Millburn

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

510(k) Number (if known):

Device Name: Interlok® Bio-Modular Shoulder Humeral Stems

Indications For Use:

    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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
    1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Non-coated (Interlok®) devices are indicated for cemented application only.

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -

(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)