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 TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Distal Stem Fatigue:
ISO 7206-4:2002, ASTM F2068-03	Passed for 5 million cycles at 67 lbs to 517 lbs (for 6 worst-case stems)
Proximal Stem Fatigue:
ISO 7206-6:1992	Passed for 10 million cycles at 120 lbs (for 6 worst-case stems)
Range of Motion Analysis:
ISO 21535:2009	Passed its simulation
PPS Plasma Sprayed Coating Characterization:	Meets the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358.

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

Sample Size for Mechanical Testing: 6 worst-case stems were used for both distal and proximal stem fatigue testing. The sample size for the Range of Motion analysis is not explicitly stated but implies at least one simulation.
Data Provenance: The data is from non-clinical testing performed by Biomet Manufacturing Corp. The country of origin is not explicitly stated, but the company is based in Warsaw, IN, USA. The data is prospective in the sense that it was generated for the purpose of this 510(k) submission, not gathered retrospectively from existing patient data.

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

This section is not applicable as the studies described are non-clinical mechanical engineering tests, not studies requiring human expert assessment of medical images or patient outcomes. The "ground truth" for these tests is defined by the international standards (e.g., ISO, ASTM) and the specified load/cycle requirements.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. There were no human expert assessments requiring adjudication. The tests were objective mechanical measurements against predefined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This device is a hip implant, and the testing described is mechanical, not related to AI-assisted human reading.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was based on internationally recognized engineering standards and specifications. Specifically:

Distal Stem Fatigue: ISO 7206-4:2002, ASTM F2068-03
Proximal Stem Fatigue: ISO 7206-6:1992
Range of Motion Analysis: ISO 21535:2009
PPS Plasma Sprayed Coating: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and 21 CFR 888.3358.

The "ground truth" is therefore adherence to these established mechanical performance and material characterization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The number of samples for mechanical testing (6 worst-case stems) served as the test set.

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

This section is not applicable for the same reason as above. There is no training set mentioned or implied.

Summary

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t : 1 4 2 2 - - 1 8 -MANUFACTURING CORP.

510(k) SummarySEP 30 2011
Preparation Date:	September 29, 2011
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587Establishment Registration Number: 1825034
Contact Person:	Becky EarlRegulatory Specialist
Proprietary Name:	Taperloc® Complete Microplasty System
Common Name:	Uncemented porous modular hip prosthesis
Classification Name:	Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent, prosthesis (21 CFR §888.3330)
	LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, PorousUncemented (21 CFR 888.3358)
	KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented AcetabularComponent) (21 CFR 888.3330)
	JDL- Prosthesis, Hip, Semi-Constrained (Metal Cemented AcetabularComponent) (21 CFR 888.3320)
	LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented or Non-Porous, Uncemented (21 CFR 888.3353)
	KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented,Metal/Polymer (21 CFR 888.3310)
	JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21CFR 888.3350)
	KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented orUncemented (21 CFR 888.3390)
	MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer,Non-Porous, Calcium-Phosphate (21 CFR 888.3353)
	KWL-Hip Joint Femoral (Hemi-Hip) Metallic Cemented or UncementedProsthesis (21 CFR 888.3360)
	OQG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porousuncemented (888.3358)

Malling Address: P.O. Box 587 Warsaw, IN. 46581-0587 800.348.9500 Toll Free: Office: 574.267.6639 574-267-8137 Main Fax: www.biomet.com

Shipping Address: 56 E Bell Drive Warsaw, IN 46582

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Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Taperloc® Complete Stems-Biomet-(K101086)

Lateralized Taperioc® Microplasty Femoral Components -Biomet-(K062994)

Taperloc® Complete, Sizes 5mm and 6mm-Biomet-(K103755)

Fitmore® Hip Stem-Zimmer-(K071723)

Device Description:

Intended Use:

Porous coated components are intended for uncemented biological fixation.

Indications for Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis
Correction of functional deformity 3.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed. 5.

Porous coated components are intended for uncemented biological fixation.

Summary of Technologies:

The technological characteristics are the same as the predicates identified in the Legally Marketed Devices to which substantial equivalence is claimed. The subject microplasty stems are designed to update the existing Taperloc® Microplasty implants (K062994) to join the Taperloc® Complete family of stems as a microplasty option. The subject microplasty stems combine the design features of the Taperloc® Complete full-length stems (K101086 and K103755) and the shortened design of the Taperloc® Microplasty stems, both standard and high offset, or lateralized (K062994). Technological characteristics include a tapered wedge, a porous plasma sprayed region, a modified shortened trunnion (Type 1), a reduced neck angle, two distal profiles and an updated insertion/extraction hole, identical to the Taperloc® Complete full-length stem predicates (K101086 and K103755). Stem lengths are within the range of the legally marketed predicates.

Non-Clinical Testing:

Nonclinical performance testing included distal and proximal stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2002, ASTM F2068-03 and ISO 7206-6:1992, as well as a Range of Motion analysis consistent with ISO 21535:2009. All 6 stems passed distal stem fatigue for 5 million cycles at 67 lbs to 517lbs,

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meeting the acceptance criteria. All 6 stems passed 10 million cycles at 120lbs in proximal fatigue test, meeting the acceptance criteria. The minimum Range of Motion passed its simulation, meeting the acceptance criteria.

Additional Ti-alloy (ASTM F1580) plasma sprayed metallic coating characterization data was performed for clarification per the "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and per the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The PPS plasma sprayed coating is the same as the PPS coating previously cleared and meets the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358.

Clinical Testing:

None provided as a basis for substantial equivalence.

The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo features a stylized depiction of three birds in flight, arranged vertically. The birds are simple, with curved lines suggesting their wings and bodies. Encircling the birds is text that follows the curve of the circle. The text is small and somewhat difficult to read, but it appears to be the name of an organization or agency.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W056-G609 Silver Spring, MD 20993-0002

Biomet Manufacturing Corp. % Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, IN 46581

cca 3 0 2711

Re: K110400

Trade/Device Name: Taperloc® Complete Microplasty System 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, LPH, JDL, LZO, KWZ, JDI. KWY, MEH, KWL, QOG Dated: September 20, 2011 Received: September 21. 2011

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. Ilisting 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

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Page - 2 -- Ms. Becky Earl

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 practive requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff 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" (21CFR 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin S. Keith

Cr 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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Indications for Use

510(k) Number (if known): _ K | 104000000001/1 )

Device Name: Taperloc® Complete Microplasty

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.

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)

ihankhens for mxm

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

510(k) Number K110400

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.