X-SERIES INTEGRAL RPP FEMORAL COMPONENTS

• K Number: K042029
• Device Name: X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2004-11-09 ( 104 days)
• Product Code: LPH
• Regulation Number: 888.3358
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K030501
• Predicate For: N/A

Intended Use

Non-cemented total joint replacement in cases of:

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 by other techniques.
5. Revision of previously failed total hip arthroplasty

Device Description

The X-Series Integral® RPP Femoral Components are identical to the predicate X-Series Integral® Femoral components in overall design. The X-Series Integral® RPP Femoral Components have a reduced proximal geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (X-Series Integral® RPP Hip Femoral Components). It describes a submission made to the FDA for market clearance, focusing on substantial equivalence to a predicate device.

Crucially, this document specifies "Clinical Testing: None provided" and "Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device."

Therefore, the following information regarding acceptance criteria and studies demonstrating that the device meets those criteria is largely not applicable (N/A) in the context of the provided text, as this type of 510(k) submission primarily relies on substantial equivalence and non-clinical data for a modified device, rather than new clinical trials with specified acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown based on your request, highlighting what is and is not present:

---

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Anticipated for Device Performance)	Reported Device Performance (from document)
Material Composition: Conforming to ASTM F-136 (Ti-6Al-4V)	Device is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.
Overall Design: Identical to predicate device	"Identical to the predicate X-Series Integral® Femoral components in overall design."
Reduced Proximal Geometry:	The X-Series Integral® RPP Femoral Components have a reduced proximal geometry.
Safety of Design Changes: No adverse effect on safety	"Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device."
Functional Equivalence: Similar/identical technological characteristics to predicate (materials, design, sizing, indications)	"The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device."
Clinical Efficacy/Safety for Indications: (No specific quantitative criteria provided in this document as it relies on predicate device's established efficacy/safety)	Indicated for non-cemented total joint replacement in cases of: Non-inflammatory degenerative joint disease, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union/fractures, Revision of previously failed total hip arthroplasty. (These indications are the same as the predicate device, implying similar expected clinical outcomes).

Note: The acceptance criteria here are inferred from the 510(k) approach, which aims for substantial equivalence to a predicate device. The primary "performance" demonstrated is that the design changes (reduced proximal geometry) do not negatively impact safety or core functionality compared to the legally marketed predicate. No specific quantitative, clinical performance metrics (like survival rates, range of motion, pain reduction scores) are listed as acceptance criteria or reported for this device in this summary, as these would typically be established for a new device or in a PMA application.

---

Details of the Study/Evidence Provided:

Since no clinical study demonstrating specific performance metrics for this device was performed or provided, many of your requested points are Not Applicable or Not Provided by the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable. No clinical test set used.
• Data Provenance: Not applicable.
• The non-clinical testing involved "Finite Element Analysis and engineering analysis." The "test set" for these would be the computer models and engineering calculations, not biological samples. Specifics of these analyses (e.g., number of FEA models, range of loads tested) are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No human experts were involved in establishing a ground truth for a clinical test set for this 510(k) submission. Engineering experts would have been involved in performing and reviewing the Finite Element Analysis and engineering analysis, but their number and qualifications are not specified in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method for a test set was used, as no clinical test set was required or presented for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a hip femoral component, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a hip femoral component. The "performance" assessment was primarily through non-clinical engineering analysis, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical testing (Finite Element Analysis and engineering analysis), the "ground truth" would be based on principles of mechanical engineering, material science, and possibly established biomechanical safety thresholds. No clinical ground truth (like pathology or outcomes data) was used for this specific device's testing. The substantial equivalence relies on the predicate device's established clinical ground truth.

8. The sample size for the training set

• Not applicable. No training set was used, as there was no algorithm or machine learning component.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

Summary

{0}------------------------------------------------

page 1 of 2

NOV - 9 2004

BIOMET

K04-2029

510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: [phone]

Proprietary Name: X-Series Integral® RPP Hip Femoral Components

Common Name: Hip replacement prosthesis

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3558)

Legally Marketed Device to which Substantial Equivalence is Claimed: X-Series Integral® Hip Femoral Component (K030501)

Device Description: The X-Series Integral® RPP Femoral Components are identical to the predicate X-Series Integral® Femoral components in overall design. The X-Series Integral® RPP Femoral Components have a reduced proximal geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.

Indications for Use: Non-cemented total joint replacement in cases of:

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

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 574.267.6639

Image /page/0/Picture/22 description: The image shows the word "FAX" at the top, followed by the number "574.267.8137" on the next line. Below that, the number "127" is printed in a larger, bold font. The image appears to be a snippet from a document, possibly a fax cover sheet or a document containing contact information.

E-MAH [e-mail]

{1}------------------------------------------------

page 2 of 2

Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.

Clinical Testing: None provided

Integral is a trademark of Biomet, Inc.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract image of an eagle with three lines representing its wings. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K042029

Ko42027
Trade/Device Name: X-Series Integral® Reduced Proximal Profile (RPP) Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prostheses. Regulatory Class: II Product Code: LPH Dated: October 11, 2004 Received: October 12, 2004

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.

{3}------------------------------------------------

Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and hy your he 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 yours,

L. Mark A. 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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: X-Series Integral® RPP Femoral Components

Indications For Use:

Non-cemented total joint replacement in cases of:

• 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 by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K0402029
Ko 92029 MN

Page 1 of 1

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.