MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS

• K Number: K030055
• Device Name: MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-08-11 ( 217 days)
• Product Code: LPH
• Regulation Number: 888.3358

Intended Use

1) Nonin'lammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheurnatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and throchanteric fractures of the oroximal femur with head involvement, unmanageable using other techniques. 5) Revision of previously failed total hip arthoplasty.

Device Description

All devices are metallic, tapered hip femoral components. Each utlizes a modular ferr oral head component that is taper fit onto the stem at the time of surgery.

Predicate Devices

K984296, K984408, K960303, K982367, K000760

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a metallic hip femoral component and its intended uses, with no mention of AI, ML, image processing, or any data-driven algorithms.

Therapeutic

Yes
The device is described as a "metallic, tapered hip femoral component" used for the "treatment of non-union, femoral neck fracture, and throchanteric fractures of the oroximal femur with head involvement, unmanageable using other techniques" and "revision of previously failed total hip arthroplasty," which are therapeutic applications.

Diagnostic

No
The device is described as a metallic, tapered hip femoral component used for surgical procedures like total hip arthroplasty, not for diagnosing diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are metallic, tapered hip femoral components, which are hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended uses listed are all related to the surgical treatment of hip joint conditions (degenerative joint disease, arthritis, fractures, revisions). These are clinical treatments performed directly on the patient.
• Device Description: The device is described as a metallic, tapered hip femoral component and a modular femoral head component. These are implantable medical devices used in surgery.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.

Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Non-cemented total hip replacement

Indications For Use:

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

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

LPH, LZO, MEH

Device Description

All devices are metallic, tapered hip femoral components. Each utilizes a modular femoral head component that is taper fit onto the stem at the time of surgery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

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 and 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.

K984296, K984408, K960303, K982367, K000760

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

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

Summary

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AUG 1 1 2003

K030055-
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BIOMET

Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet Orthopedics, Inc.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name(s): MalloryHead® Total Hip System, HA Mallory/Head® Total Hip System, Bi-Metric® Fer ioral Components, HA Bi-Metric® Femoral Component, Taperloo® Femoral Component, HA Taperloc® Fer ioral Component, Integral® Femoral Component, Modular Hip Stems, HA Modular Reach®, APF Fer noral Component. PMI® Femoral Component. Universal® Acetabular Component, Index® Acetabular Cor poner t, A-B (Precept®) Acetabular Component, Pegged Acetabular Component, Flanged Acetabular Cornponer t

Common or Usual Name: Total Hip Prostheses

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFIX 888.3358)

Device Product Code(s): LPH, LZO, MEH

Lec ally Marketed Devices To Which Substantial Equivalence Is Claimed:

Lateralized Integral® Femoral Component - K984296 130° Integral® Femoral Component - K984408 Fenning (Osteocap RS®) Femoral Component - K960303 Reach® Femoral Component - K982367, K000760

Device Description: All devices are metallic, tapered hip femoral components. Each utlizes a modular ferr oral head component that is taper fit onto the stem at the time of surgery.

Int« nded Use: Non-cemented total hip replacement

Sunnmary of Technologies: The devices to be covered by this 510(k) for expanded indications are gec metrically identical to devices previously covered by 510(k).

Clinical and Non-Clinical Testing: None provided

All t ademarks are property of Biomet. Inc.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX [phone] (Mix

E-MAII. [e-mail]

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Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". In the center of the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

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

Re: K030055

Trade/Device Name: Expanded Indications for Non-Cemented Porous Coated Total Hip Prostheses Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH and MEH Dated: May 22, 2003 Received: May 23, 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

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Page 2 - Ms. Patricia Sandborn Beres

forth in the quality systems (OS) 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 may be obtained 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 yours,

Lily Webb

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

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Expanded Indications for Non-Cemented Porous Coated Total Hip Prostheses

Indications For Use:

• 1. Nonin'lammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheurnatoid arthritis
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture, and throchanteric fractures of the oroximal femur with head involvement, unmanageable using other techniques.
• 5. Revision of previously failed total hip arthoplasty.

Alan Witt
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K030055

(PL :ASE 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 \lrcorner$_{0}$

(Optional Format 1-2-96)

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