RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS

• K Number: K032396
• Device Name: RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-08-21 ( 17 days)
• Product Code: JDI LPH
• Regulation Number: 888.3350

Intended Use

The indications for use of the Biomet hip replacement prosthesis include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. These devices are intended for either cemented or uncemented use.

Device Description

The RingLoc® 36mm Liners are manufactured from ArCom® processed ultra-high molecular weight polyethylene (UHMWPE) conforming to ASTM F648. The Modular Femoral Heads are manufactured from wrought Co-Cr-Mo conforming to ASTM F1537. They incorporate the standard Biomet Type I taper and come in neck sizes -- 6mm, -3mm, STD, +3mm, +6mm, +9mm, and +12mm. The +9mm and +12mm heads incorporate a skirt to maintain the same point of rotation.

Predicate Devices

K970501, K974558

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical hip replacement prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is a hip replacement prosthesis used to treat degenerative joint diseases and fractures, which falls under the definition of a therapeutic device.

Diagnostic

No

Explanation: The device is a hip replacement prosthesis, which is an implant used to replace a damaged hip joint, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a hip replacement prosthesis made of physical materials (UHMWPE and Co-Cr-Mo) and includes components like liners and femoral heads. This indicates a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

No, 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 provided text describes a hip replacement prosthesis, which is an implantable medical device used to replace a damaged hip joint.
• Intended Use: The intended uses listed are all related to the surgical treatment of hip joint conditions and injuries.
• No Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.

Therefore, based on the provided information, the Biomet hip replacement prosthesis is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RingLoc® 36mm Liners and Modular Femoral Heads are intended for either cemented of uncemented use.

The indications for use of the Biomet hip replacement prosthesis include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
• 5. Revision of previously failed total hip arthroplasty.

These devices are intended for either cemented or uncemented use.

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

JDI, LPH

Device Description

The RingLoc® 36mm Liners are manufactured from ArCom® processed ultra-high molecular weight polyethylene (UHMWPE) conforming to ASTM F648. The Modular Femoral Heads are manufactured from wrought Co-Cr-Mo conforming to ASTM F1537. They incorporate the standard Biomet Type I taper and come in neck sizes -- 6mm, -3mm, STD, +3mm, +6mm, +9mm, and +12mm. The +9mm and +12mm heads incorporate a skirt to maintain the same point of rotation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint, proximal femur

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)

Mechanical testing and published literature determined that 36mm liners and heads presented no new unacceptable risks, and are therefore, substantially equivalent to the predicate devices.

No clinical testing was necessary for determination of 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.

K970501, K974558

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

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular 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.

Summary

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AUG 2 1 2003

BIOMET

032396
page 1 of 2

510(k) Summary

Biomet Orthopedics, Inc. Applicant/Sponsor: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Contact Person: Gary Baker 56 East Bell Drive P.O. Box 587 Warsaw. IN 46581-0587 Telephone: [phone] Ext. 1568

• Proprietary Name: RingLoc® 36mm Liners and Modular Femoral Heads
  Fax: [phone]

• Acetabular liners and femoral heads. Common Name:

• Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (21 CFR 8888.3358), and hip joint metal/polymer semiconstrained cemented prosthesis (21 CFR 888.3350).

• Legally Marketed Devices To Which Substantial Equivalence Is Claimed: RingLoc® 32mm Liners cleared in 510(k) K970501, and 32mm Modular Femoral Heads cleared in 510(k) K974558.

Device Description:

The RingLoc® 36mm Liners are manufactured from ArCom® processed ultra-high molecular weight polyethylene (UHMWPE) conforming to ASTM F648. The Modular Femoral Heads are manufactured from wrought Co-Cr-Mo conforming to ASTM F1537. They incorporate the standard Biomet Type I taper and come in neck sizes -- 6mm, -3mm, STD, +3mm, +6mm, +9mm, and +12mm. The +9mm and +12mm heads incorporate a skirt to maintain the same point of rotation.

Intended Use:

The RingLoc® 36mm Liners and Modular Femoral Heads are intended for either cemented of uncemented use.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582

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OFFICE 574.267.6634)

FAX [phone] '

E-MAH [e-mail]

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32396
page dofa

Summary of Technologies:

The RingLoc® 36mm Liners and Modular Femoral Heads are manufactured from the same materials, utilizing the same manufacturing practices, and conforming to the same standards as the predicate devices.

Non-Clinical Testing:

Mechanical testing and published literature determined that 36mm liners and heads presented no new unacceptable risks, and are therefore, substantially equivalent to the predicate devices.

Clinical Testing:

No clinical testing was necessary for determination of substantial equivalence.

All trademarks are property of Biomet, Inc

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Mr. Gary Baker Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K032396

Trade/Device Name: RingLoc® 36mm Liners and Modular Femoral Heads Regulation Numbers: 21 CFR 888.3350, 21 CFR 888.3358 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: JDI, LPH Dated: August 1, 2003 Received: August 4, 2003

Dear Mr. Baker:

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. Iisting 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

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Page 2 - Mr. Gary Baker

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N Milham

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

4

Statement of Indications For Use

510(k) Number (IF KNOWN): KO32396

Device Name: RingLoc® 36mm Liners and Modular Femoral Heads

Indications for Use:

The indications for use of the Biomet hip replacement prosthesis include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
• 5. Revision of previously failed total hip arthroplasty.

These devices are intended for either cemented or uncegsen

Mark Mekers

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

(PLEASE DO NOT WRITE BELOW THIS LINE - COMIT)NUBOW 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)

2000