Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

Device Description

The Biolox® delta component is a traditional, one-piece ceramic head indicated for hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. The ceramic heads are available in three sizes, with several offsets.

The scope of this submission is:

An inner taper change and distal face change requested by CeramTec for the purpose of increased burst strength and increased cost effectiveness.
The one remaining size is previously cleared through K061312 and K073102. This submission seeks to incorporate all of Biomet's Biolox® delta Ceramic Heads (Monobloc) under unified Indications, Contraindications, Instructions for Use and labeling.

AI/ML Overview

This document is a 510(k) Summary for the Biomet Biolox® delta Ceramic Heads, a medical device used in hip arthroplasty. The summary is intended to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Performed)	Reported Device Performance
Burst testing to assess worst case	(Implied to meet acceptable levels, as substantial equivalence was determined)
Fatigue burst test	(Implied to meet acceptable levels, as substantial equivalence was determined)
Post-fatigue burst test	(Implied to meet acceptable levels, as substantial equivalence was determined)
Pull-off test on CoCrMo tapers	(Implied to meet acceptable levels, as substantial equivalence was determined)
Rotational stability on CoCrMo tapers	(Implied to meet acceptable levels, as substantial equivalence was determined)
Modifications do not introduce any new risks of safety or efficacy	Testing demonstrates that the modifications made to the Biolox® delta Ceramic Heads (Monoblock) do not introduce any new risks of safety or efficacy, and that the Biolox® delta Ceramic Heads (Monoblock) are substantially equivalent to the predicates. (This is a summary conclusion of all non-clinical tests.)

2. Sample Size for the Test Set and Data Provenance:

The document focuses on non-clinical testing of a physical medical device (ceramic femoral head). Therefore, the concept of a "test set" for data (like in software or AI models) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable in the same way. The "test set" here refers to the samples of ceramic heads and associated components used for the physical and mechanical tests.

Sample Size for Test Set: The exact sample sizes for each specific test (burst, fatigue, pull-off, rotational stability) are not explicitly stated in this summary. The document mentions "worst case" testing, which implies specific configurations or conditions were selected for testing.
Data Provenance: Not applicable in the context of physical device testing. The tests are conducted on manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the document describes physical and mechanical testing of a medical device, not a diagnostic or AI-driven system that relies on expert interpretation for ground truth. The "ground truth" for these tests would be the established engineering standards and acceptable performance limits for orthopedic implants.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Physical test results are objectively measured against established criteria, not subject to expert adjudication.

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:

This information is not applicable. This document describes the 510(k) submission for a physical medical device (ceramic femoral head), not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as the document is about a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used for this device's testing is based on established engineering standards, material science principles, and functional requirements for orthopedic implants. The tests (burst strength, fatigue, pull-off, rotational stability) are designed to verify that the device meets these pre-defined physical and mechanical performance characteristics relevant to its intended use and safety. The comparison is against predicate devices which have already been deemed safe and effective based on similar physical tests.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of physical medical device testing for 510(k) clearance. This is not an AI or machine learning device. The manufacturing process and quality control would involve ongoing testing, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reasons as point 8.

Summary

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BIOMET
Inc.

510(k) Summary

OCT 10 2013

Preparation Date:
October 9, 2013

Sponsor:
Biomet UK Ltd.
Waterton Industrial Estate
Bridgend, South Wales, UNITED KINGDOM CF31 3XA
FDA Registration Number: 9044936
Telephone: +44(0) 1656 655221

Correspondent
Biomet Manufacturing Corp.
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581-0587
Establishment Registration Number: 1825034
Telephone: (574) 267-6639

Contact Person:
Becky Earl
Regulatory Specialist

Proprietary Name:
Biolox® delta Ceramic Heads

Common Name:
Femoral Ceramic Head, Monoblock

Classification Name:
LZO—Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented
or Non-Porous, Uncemented (21 CFR 888.3353)

LPH—Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
(21 CFR 888.3358)

OQG—Prosthesis, hip, semi-constrained, metal/polymer + additive, porous
uncemented (21 CFR 888.3358)

LWJ—prosthesis, hip, semi-constrained, metal/polymer, uncemented
(21 CFR 888.3360)

JDI— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
(21 CFR 888.3350)

OQH—Hip, semi-constrained, cemented, metal/polymer + additive, cemented
(21 CFR 888.3350)

Mailing Address P.O. Box 587 Warsaw, IN 46581-0587 Toll Free 800 348.9500 Office. 574.267.6639 Main Fax: 574 267.8137 ww biomet.com

Shipping Address: 56 East Bell Drive . Warsaw, IN 45582

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001-Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21 CFR 888.3353)

MAY—Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish (21 CFR 888.3353)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Biolox® delta Ceramic Heads-Biomet-(K042091)

36mm Biolox® delta Ceramic Heads-Biomet—(K061312)

Biolox® delta Ceramic Head-Zimmer-(K071535)

Device Description:

The scope of this submission is:

An inner taper change and distal face change requested by CeramTec for the purpose of increased . burst strength and increased cost effectiveness.
The one remaining size is previously cleared through K061312 and K073102. This submission seeks . to incorporate all of Biomet's Biolox® delta Ceramic Heads (Monobloc) under unified Indications, Contraindications, Instructions for Use and labeling.

Indications for Use:

Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and 1. traumatic arthritis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur 4. with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed. 5.

Specific indications for compatible components that can be used with the above modular heads include:

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Summary of Technologies:

The technological characteristics of the proposed device are the same as or similar to the predicates. The Biolox® delto Ceramic Heads are similar in design, dimensions, and intended use as their predicates. They are made of the same material as all their predicates, and indications are similar or the same as all the predicates. There have been no changes to the larger size.

Non-Clinical Testing:

New testing to support the argument for substantial equivalence includes the following: Burst testing to assess the worst case and further testing on worst case to include: Fatigue burst test; Post-fatigue burst test; Pull-off test on CoCrMo tapers; and Rotational stability on CoCrMo tapers.

Clinical Testing:

None provided as a basis for substantial equivalence.

Testing demonstrates that the modifications made to the Biolox® delta Ceramic Heads (Monoblock) do not introduce any new risks of safety or efficacy, and that the Biolox® delta Ceramic Heads (Monoblock) are substantially equivalent to the predicates.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be three stylized lines, possibly representing a bird or a similar abstract design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2013

Biomet UK Limited % Ms. Becky Earl Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana· 46581

Re: K131684

Trade/Device Name: Biolox® delta Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LPH, OQG. LWJ, JDI, OQI-I Dated: September 10, 2013 Received: September 12, 2013

Dear Ms. Earl:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however. that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA), it may be subject to 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 complics 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Becky Earl

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Biolox® delta Ceramic Heads

Indications For Use: Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

1. Non-inflammatory degenerative ioint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the oroximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, turnor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)*

*Note - for the USA only

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

Over-The-Counter Use NO (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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.