This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; 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 arthroplasty or other procedure.

Device Description

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.

However, based on the text, the following can be inferred:

Test Performed	Implied Acceptance Criteria	Reported Device Performance
Burst Test	Demonstrated performance comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure structural integrity and resistance to sudden failure.	"demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.)
Fatigue Test	Demonstrated performance comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure durability and resistance to failure under prolonged or cyclical loading.	"demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.)
Burst Test for Post-Fatigue	Demonstrated structural integrity after undergoing fatigue testing, comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems."	"demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.)
Rotational Resistance Test	Demonstrated rotational stability comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to prevent unwanted rotation between components.	"demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.)
Pull-off Test	Demonstrated pull-off strength comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure secure attachment of the femoral head.	"demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.)

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

The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed on newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.

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 and not provided in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning model that requires a training set.

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

This information is not applicable and not provided in the document, as there is no training set mentioned.

Summary

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K112463*"1/3

(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K)

510(k) Summary

510(k) Summary of Safety and Effectiveness

Submitted by:	United Orthopedic Corporation
Address:	No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan
Phone Number:	+886-3-5773351 ext. 212
Fax Number:	+886-3-577156
Date of Summary:	August 25, 2011
Contact Person	Fang-Yuan HoRegulation and Document Management
Proprietary Name:	36 mm Ceramic Femoral Head, Delta
Common Name:	Semi-constrained total hip prostheses
Device Classification	Hip joint metal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis under 21CFR 888.3353This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	LZO, MEH, LPH
Predicate Device:	1. "UNITED" Ceramic Femoral Head, manufactured byUnited Orthopedic Corporation, K103497, cleared March04, 20112. Smith & Nephew BIOLOX® Delta Ceramic FemoralHeads (K083762, K100412)3. BIOMET BIOLOX® Delta Ceramic Heads (K042091,K061312, K051411)

Device Description:

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the

Page: Summary-1/3

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(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K) 510(k) Summary

previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

Intended Use

"UNITED" 36 mm Ceramic Femoral Head - Delta is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; 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 arthroplasty or other procedure.

Basis for Substantial Equivalence:

The safety and effectiveness of 36 mm Ceramic Femoral Head - Delta are substantially Page: Summary-2/3 UOC-FDA-019

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(0) 36 mm Ceramic Femoral Head, Delta: Special 510 (K) 510(k) Summary

equivalent to the previously cleared Ceramic Femoral Head (K103497), except for an extension in the size distribution. The modifications do not change the intended use or fundamental scientific technology. In addition, the subject device is also substantial equivalence to the Smith & Nephew BIOLOX® Delta Ceramic Femoral Heads (K083762, K100412) and BIOMET BIOLOX® Delta Ceramic Heads (K042091, K061312, K051411).

Performance Data:

This 510(k) was prepared in accordance with "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems". Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows a circular logo with an abstract bird design in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text, which appears to be part of the logo's name or a related phrase. The overall design is simple and symbolic, likely representing a company or organization associated with aviation, nature, or a similar field.

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

United Orthopedic Corporation % Fang-Yuan Ho Regulatory Affairs Manager 57 park Ave. 2, Sience Park Hsinchu, China (Taiwan) 300

SEP 23 2011

Re: K112463 Trade/Device Name: 36mm Ceramic Femora Head, Delta Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/ polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: LZO, MEH, LPH Dated: August 16. 2011 Received: August 26, 2011

Dear Fang-Yuan Ho:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Fang-Yuan Ho

forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 331-542 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" (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/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.

E.O. Keith

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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Indication for Use

510 (k) Number (if known): مالاس2 (if known): 510)

Device Name: 36 mm Ceramic Femoral Head, Delta

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Owens for mxm

gical, Orthopedic, Restorative Devic

Page 1 of l

510(k) Number K112463

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.