This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision procedures where other treatments or devices have failed.

This device is designed for cementless use.

Device Description

This subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem-Reduced except for its large size. As the same as the cleared UTF Stem-reduced (K123550), the subjected device forged from Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580).

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "UTF Stem-reduced, Additional Sizes," which is a hip stem. The submission is for a size extension to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical properties of the device are adequate.	"The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device (#12~#14) is not the worst case within all sizes of UTF Stem-reduced (#1~#14)."
Device modification does not affect safety and effectiveness.	"This device modification would not affect the safety and effectiveness."
Substantial Equivalence to Predicate Device.	The subject device is deemed "substantially equivalent" to the predicate "UNITED" UTF Stem-Reduced (K123550). This implies it meets similar performance and safety standards as the predicate.

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

The submission does not provide details on a specific "test set" in the context of clinical data or a test group of patients. The performance data is based on a mechanical evaluation of the device sizes #12-#14.
- Sample size for test set: Not applicable in the context of clinical data. The mechanical evaluation was performed on device sizes #12-#14.
- Data provenance: Not applicable. The performance data is from a mechanical evaluation rather than patient data.
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. The study is a mechanical evaluation and does not involve establishing ground truth from expert clinical review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The study is a mechanical evaluation.
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 MRMC comparative effectiveness study was done. This device is a hip stem, a physical implant, not an AI or imaging device that would typically involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the mechanical performance standards for hip stems, which the device's mechanical properties were evaluated against. This is not clinical ground truth (like pathology or outcomes data) but rather engineering and material science standards for device integrity and function.
The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
How the ground truth for the training set was established

Not applicable. There is no training set for a physical medical implant.

Summary

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

UTF Stem-reduced, Additional Sizes

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. 2212
Fax Number:	+886-3-577156
Date of Summary:	July 15, 2013
Contact Person	Fang-Yuan HoAUG 3 0 2013
	Regulation and Document Management
Proprietary Name:	UTF Stem-reduced, Additional Sizes
Common Name:	Hip stem
Device Classification	Hip joint metal/polymer/metal semi-constrained porous-coated
Name and Reference:	uncemented prosthesis under 21CFR 888.3358This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	LPH, KWY, LZO
Predicate Device:	"UNITED" UTF Stem, Reduced (K123550)

Device Description:

Page: 7-1/2

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

O UTF Stem-reduced, Additional Sizes

Indications:

This device is designed for cementless use.

Basis for Substantial Equivalence:

The subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550). The indications, materials, design, manufacturing process and sterilization method of the subject device are identical to the cleared "UNITED" UTF Stem-Reduced (K123550).

Performance Data:

The mechanical properties of this device have been evaluated, and the analysis results shown that this subjected device (#12~#14) is not the worst case within all sizes of UTF Stem-reduced (#1~#14). This device modification would not affect the safety and effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES-USA" and "DEPARTMENT OF" are arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenne Document Control Center - W(%6-(1609 Silver Spring, MD 20993-0002

August 30, 2013

United Orthopedic Corporation % Ms. Fang-Yuan Ho No 57, Park Ave 2, Science Park . Hsinchu 300 Taiwan

Re: K132207 Trade/Device Name: UTF Stem-reduced, Additional Sizes Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPI-, KWY, LZO Dated: July 31, 2013 Received: August 1, 2013

Dear Ms. 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 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 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, I-DA 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

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

Page 2 - Ms. Fang-Yuan Ho

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 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/Resourcesfor You/Industry/default.htm. 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 I. Keith

For

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

Enclosure

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

Indication for Use

K132207 510 (k) Number (if known):

Device Name: UTF Stem-reduced, Additional Sizes_

Indications for Use:

This device is designed for cementless 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)

Page l of l

Elizabeth L. Frank -S

Division of Orthopedic Devices

UOC-FDA-029

. Page: 6-1/1

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.