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 modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The materials, safety and effectiveness of this subject device are identical to "UNITED" UTF Stem (K110245). Compared with the UTF Stem (K110245), the distal width of UTF Stem-reduced is reduced to provide more selection for clinical demand, and the thread diameter of impact hole of UTF Stem-reduced is enlarged to increase the mechanical strength of stem holder which is locked with impact hole.

As the same as UTF Stem (K110245), UTF Stem-reduced, forged from a Ti-6A1-4V alloy (ASTM F136), is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle. The proximal part of each femoral stem is plasma coated with CP Ti powder (ASTM F1580) in thickness 500±127μm. UTF Stem-reduced is available with standard and high offset options, and each,type is available in sizes #1~~11. The specifications of UTF Stem-reduced in size #1~~6 and #9 are identical with UTF Stem (K110245) in size #7.5, 9, 10, 11, 12, 13, 16.5, respectively, while size #7, 8, 10 and 11 are new items which is between size # 13 and #22 in UTF Stem (K110245). These modifications will not affect its safety and effectiveness.

For total hip replacement, UTF Stem-reduced can be used in conjunction with UNITED Femoral Head (K994078, K022520, K111546 and K122504), Ceramic Femoral Head (K103497, K112463), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K12177), U2 Ti Plasma Spray Cup (K050262, K121777) and U2 Ti Porous Coated Cup (K111546). As using with U2 Acetabular Cup Liner (K050262), UTF Stem-reduced can be used with 26 mm and 28 mm metal Femoral Head (K994078, K022520, K122504) and 28 mm Ceramic Femoral Head (K103497). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546, K122504) and 28 i mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463).

For bipolar hip replacement, UTF Stem-reduced also can be used in conjunction with 26 mm, 28 mm, 32mm and 36mm metal Femoral Head (K994078, K022520, K111546, K122504), 28 mm, 32 mm and 36 mm Ceramic Femoral Head (K103497, K112463) and Bipolar implants (K101670). UNITED Femoral Head and Bipolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Stem fatigue strength conformance (ISO 7206-4)	Not numerically stated, but FEM analysis indicated that modifications did not decrease strength. The predicate device's (UTF Stem K110245) stem fatigue test was completed per ISO 7206-4.
Neck fatigue strength conformance (ISO 7206-6)	Not numerically stated, but FEM analysis indicated that modifications did not decrease strength. The predicate device's (UTF Stem K110245) neck fatigue test was completed per ISO 7206-6.
Chemical analysis of modified coating	Conforms to FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants..."
Microstructural characterization of modified coating	Conforms to FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants..."
Mechanical strength of modified coating	Conforms to FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants..."

Study Information

This submission is for a medical device (UTF Stem, reduced) and does not involve an AI/ML-based diagnostic or prognostic device, therefore many of the typical questions related to such studies (sample size for test/training sets, ground truth establishment, MRMC studies) are not applicable. The provided document is a 510(k) summary for a modified orthopedic implant. The "study" described is primarily non-clinical engineering analysis and refers to previous testing of a predicate device.

Sample size used for the test set and the data provenance: Not applicable. No specific "test set" in the context of image-based or data-driven AI diagnostics is mentioned. The non-clinical testing involved mechanical testing of the predicate device and engineering analysis of the modifications to the subject device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of expert review for diagnostic accuracy is mentioned.
Adjudication method for the test set: Not applicable.
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 study was done, as this is not an AI/ML-based device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-based device.
The type of ground truth used: For the non-clinical testing of the predicate device, the "ground truth" was defined by international standards (ISO 7206-4 and ISO 7206-6) for mechanical performance criteria. For the modified coating, it was conformance to FDA Guidance.
The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Basis for Acceptance

The submission is for a modification and size extension to a previously cleared hip stem ("UNITED" UTF Stem, K110245). The core argument for acceptance is substantial equivalence to the predicate device.

Non-Clinical Testing of Predicate Device: The predicate device (UTF Stem K110245) had its stem fatigue test completed according to ISO 7206-4 and its neck fatigue test according to ISO 7206-6. These tests established the performance benchmarks for the original design.
Engineering Analysis for the Subject Device (UTF Stem, reduced): For the new "UTF Stem, reduced" device, no additional non-clinical mechanical testing was performed on the stem itself. Instead, the manufacturer relied on Finite Element Method (FEM) analysis. This analysis concluded that the modifications (reduced distal width and enlarged thread diameter of the impact hole) did not decrease the stem fatigue strength or neck fatigue strength compared to the predicate device.
Materials Testing: For the modified coating, chemical analysis, microstructural characterization, and mechanical strength were evaluated. The results were found to conform to the requirements of the FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements."
Clinical Testing: No clinical testing was required or performed for this submission, further indicating the reliance on substantial equivalence and non-clinical data.
Conclusion: Based on the engineering analysis of the design modification and the materials testing, the manufacturer determined that the "UTF Stem, reduced" is substantially equivalent to legally marketed predicates, meaning it is considered "as safe, as effective, and performs at least as safely and effectively."

Summary

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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. 2212
Fax Number:	+886-3-5777156
Date of Summary:	November 15, 2012
Contact Person:	Fang-Yuan Ho
	Manager, Regulatory Affairs	Proprietary Name:	UTF Stem, reduced	Common Name:	Hip Stem	Device Classification	Hip joint metal/polymer/metal semi-constrained porous-coated	Name and Reference:	uncemented prosthesis under 21CFR 888.3358	Device Class	Class II	Panel Code	Orthopaedics Device	Device Product Code	LPH, KWY, LZO
Manager, Regulatory Affairs
Proprietary Name:	UTF Stem, reduced
Common Name:	Hip Stem
Device Classification	Hip joint metal/polymer/metal semi-constrained porous-coated
Name and Reference:	uncemented prosthesis under 21CFR 888.3358
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code	LPH, KWY, LZO
Predicate Device:	"UNITED" UTF Stem (K110245)

Device Description:

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Indications:

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.

Basis for Substantial Equivalence:

The subject device is a modification and an additional size extension to the previously cleared "UNITED" UTF Stem (K110245). The safety and effectiveness of the subject device are substantially equivalent to the previously cleared "UNITED" UTF Stem (K110245), except for the reduced distal profile and increased the thread diameter of the impact hole. The modifications do not change the intended use or fundamental scientific technology.

Non-Clinical Testing:

The stem fatigue test and neck fatigue test for worst-case in UTF stem (K110245) have been completed according to ISO 7206-4 and ISO 7206-6, respectively. No additional non-clinical testing was performed for UTF Stem-reduced because the enlarged thread diameter of impact hole and reduced distal width did not decrease the stem fatigue strength and neck fatigue strength based on the FEM analysis.

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510(k) Summary

The chemical analysis, microstructural characterization and mechanical strength of the modified coating have also evaluated. The results conform to the requirements of FDA Guidance, "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".

Based upon engineering analysis of the design modification, UTF Stem-reduced is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally market predicates.

Clinical Testing:

Clinical testing was not required for this submission.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Letter dated: May 1, 2013

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

Re: K123550 Trade/Device Name: UTF Stem, reduced 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: LPH, KWY, LZO Dated: April 3, 2013 Received: April 4, 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 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 - Ms. Fang-Yuan Ho

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,

Mark Nimelkerson -S

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

Enclosure

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Indication for Use

510 (k) Number (if known):__K123550

Device Name: UTF Stem, reduced

Indications for Use:

This device is designed for cementless use.

Prescription Use __x (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)

Elizabeth词语rank -S

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Division of Orthopedic Devices

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.