The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.

Indications For Use:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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.

Porous coated components are intended for uncemented biological fixation.

Device Description

The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Taperloc® Complete, Sizes 5mm and 6mm:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Test)	Device Performance
Distal Pot Fatigue Testing (ASTM F-1612-95)	All components passed.
Proximal Pot Fatigue Testing (ASTM F-2068-03)	All components passed.

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

The document does not explicitly state the specific sample size (i.e., number of stems) used for the non-clinical fatigue tests. It only mentions "All components passed."

The data provenance is from non-clinical testing conducted in accordance with ASTM standards. This implies laboratory testing rather than human subject data. Therefore, questions of country of origin and retrospective/prospective do not apply in the typical sense for clinical studies.

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 studies were non-clinical fatigue tests based on established ASTM standards, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were non-clinical fatigue tests. Adjudication methods are typically relevant for clinical trials where multiple evaluators assess outcomes and discrepancies need to be resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission describes a medical device (hip stems) and its non-clinical performance, not an AI-assisted diagnostic or interpretative tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to the performance requirements specified in the respective ASTM standards:

ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion: The standard itself defines the pass/fail criteria for the fatigue test.
ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants: This standard specifies the requirements for femoral prostheses, including fatigue testing, and defines what constitutes a "pass."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, and the testing described is non-clinical performance evaluation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above.

Summary

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1/21/11
K103755

JUNET . * MANUFACTURING CORP.

510(k) Summary

Preparation Date:	December 22, 2010
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587FDA Registration Number: 1825034
Contact Person:	Becky EarlRegulatory SpecialistBiomet Manufacturing Corp.Phone: (574) 267-6639Fax: (574) 372-1683becky.earl@biomet.com
Proprietary Name:	Taperloc® Complete, Sizes 5mm and 6mm
Common Name:	Uncemented porous modular hip prosthesis.
Classification Code(s)/Name(s):	LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis (21 CFR §888.3353)KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent, prosthesis (21 CFR §888.3330)KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis(21 CFR§888.3310)JDL - Hip joint metal/metal semi-constrained, with a cemented acetabularcomponent, prosthesis (21 CFR §888.3320)JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR§888.3350)MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis (21 CFR §888.3353)MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis (21 CFR §888.3353)LPH- Hip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis (21 CFR §888.3358)

Malling Address:
P.O. Box 587 1107 - 10:153w, IN 46581-0587
Toll Free: 800,348.9500 Office: 574.267.6639 Main Fax: 574.287.8137
www.biomel.com Shipping Address: 56 E. Bell Drive
Warsaw, IN 46582

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KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR§888.3360) LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360) KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR §888.3390)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Taperloc® Complete, K101086

Device Description:

The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.

Intended Use:

The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.

Indications For Use:

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

Porous coated components are intended for uncemented biological fixation.

Summary of Technologies:

The Taperloc® Complete, Size 5mm and 6mm hip stems are a line extension to the predicate Taperloc hip stems cleared in K101086. The subject stems are manufactured from the same materials, conforming to the same standards, as the predicate Taperloo stems. The Indications for Use have remained the same.

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Non-Clinical Testing:

Non-clinical fatigue testing was conducted to demonstrate that the modifications proposed in this submission raise no new issues of safety and effectiveness of the modified components as compared to the predicate hip stems.

Distal Pot Fatigue testing was conducted in accordance with ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion. All components passed distal pot cyclic fatigue testing.

Proximal Pot Fatigue testing was conducted in accordance with ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants. All components passed distal pot cyclic fatigue testing.

Clinical Testing:

Clinical testing is not necessary to demonstrate substantial equivalence to the predicate components.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

JAN 2 1 201

Re: K103755

Trade/Device Name: Taperloc® Complete, Sizes 5mm and 6mm Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LZO, KWZ, JDL, JDI, MAY, MEH, LPH, KWL, LWJ, KWY Dated: December 22, 2010 Received: December 23, 2010

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 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. 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 II (Special Controls) or class III (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 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); medical device reporting (reporting of medical

. .

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Page 2 - Ms. Becky Earl

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

F. R. Petham

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

Enclosure

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K103755

Page I of I

Indications for Use

510(k) Number (if known):_

Taperloc® Complete, Sizes Smm and 6mm Device Name: __

Indications For Use:

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

Porous coated components are intended for uncemented biological fixation.

Prescription Use X (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)

for M. Melbern

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

51.0(k) Number K103755

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.