The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.

Device Description

The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem. It states very clearly that no clinical testing was provided as a basis for substantial equivalence.

Therefore, the following information cannot be extracted from the document:

Acceptance Criteria and Reported Device Performance: This would typically be based on clinical or comparative performance data, which is explicitly stated as not having been provided.
Sample size used for the test set and data provenance: No clinical test set was used.
Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
Adjudication method for the test set: Not applicable as no clinical test set was used.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no human-in-the-loop study was conducted.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
Type of ground truth used: Not applicable as no ground truth based on clinical data was used.
Sample size for the training set: Not applicable as there is no mention of a "training set" in the context of device development.
How the ground truth for the training set was established: Not applicable.

The basis for substantial equivalence was Non-Clinical Testing, specifically "Mechanical Testing with an Engineering Justification" which determined that the components presented no new risks and were substantially equivalent to predicate devices. The predicate devices are listed as the Mallory/Head® Porous Femoral Stem (K921181) and Mallory/Head® Lateralized Press-Fit Femorals (K000538 and K003429).

This means the acceptance criteria and performance are based on engineering standards and mechanical properties, not clinical outcomes from a study involving human subjects or expert assessment of data. The document does not provide specific numerical acceptance criteria or performance metrics from this mechanical testing, only that it "determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."

Summary

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CORPORA RTERS

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Contact Person:

Dalene T. Binkley Telephone: (574) 267-6639

Proprietary Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem

Common Name: Prosthetic Hip Joint – Hydroxyapatite (HA) Coated Porous Femoral Stem

Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, nonporous, calcium-phosphate

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429.

Device Description: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.

Indications for Use: The indications for the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are for ) Non-inflammatory 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; and 5) Revision procedures where other treatments or devices have failed.

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

프

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

00100

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biomet.com

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001.09

Summary of Technologies: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical Testing with an Engineering Justification determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' 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.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 31 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021403

Trade/Device Name: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem

Regulation Number: 21 CFR 888.3358

Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: II Product Code: MEH, LPH Dated: April 26, 2002 Received: May 2, 2002

Dear Ms. Binkley:

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.

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Page 2 – Ms. Dalene T. Binkley

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin manisang your device of your device to a legally premaired 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 II you desire specific acrited to: your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fart 607.10 for his raily, for questions on the promotion and advertising of Compliance at (301) 291 1659 - 1550 - 155ce of Compliance at (301) 594-4639. Also, please note the your device, prease connecting by reference to premarket notification" (21CFR Part 807.97). It guiation entitued, "Nilostanang oresponsibilities under the Act may be obtained from the Outcl general information on your step 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,

R. Mark H. Millman

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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Page _ of _

510 (k) NUMBER (IF KNOWN): _ K O 21 4 v 3

DEVICE NAME: HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem

INDICATIONS FOR USE:

(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

KO21403

Over-The-Counter-Use $\underline{No}$
(Optional Format 1-2-96)

Mark n Milkesen

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

510(k) Number_

00009

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.