The ZENITH Hip System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

Device Description

The ZENITH Hip System (ZHS) offers a proximally porous and nonporous femoral stem component each compatible with all femoral heads, acetabular components, and cancellous bone screws of the Helicon Hip System (HHS). The porous ZHS stems are manufactured from forged Titanium (Ti) alloy, and employ a porous-coating made from commercially pure Ti (CPTi) beads. The nonporous ZHS stems are manufactured from forged cobalt chrome (CoCr) alloy. The porous Ti stem is a straight, collarless design available in 6 sizes ranging from 10 to 15mm. The nonporous CoCr stem is a straight, collared design available in 8 sizes ranging from 8 to 15mm. Both stems feature a neck-shaft angle of 128°, a 12/14 Morse taper trunnion, neck relief, and a cylindrical fluted shaft. A distal centralizer manufactured from polymethylmethacrylate (PMMA) is available for cemented applications of the CoCr stem.

The ZHS also includes 36mm femoral heads and acetabular cups. The heads are manufactured from forged or wrought CoCr alloy. The 36mm inserts are manufactured from conventional UHMWPE. The heads are highly polished and are available in four neck offsets (-5mm, Neutral, +5mm, +10mm). The heads incorporate an identical female 12/14 Morse taper used on all predicate HHS CoCr heads. The 36mm inserts are compatible with predicate HHS acetabular shells ranging in size from 56 to 68mm. Refer to the compatibility table (new Attachment 1 of the September 12, 2012 Al response/Supplement 1 ). The 36mm inserts are offered in neutral or 10 degree hooded configurations. Hooded inserts include an X-ray marker manufactured from wrought Ti alloy. The 36mm heads and mating inserts are also compatible with the Helicon Hip System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ZENITH Hip System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (hip implant), which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI algorithm or human-in-the-loop performance. The "acceptance criteria" here refer to meeting performance standards for mechanical integrity and design equivalence, not for diagnostic accuracy or human performance with AI.

The "study" in this context is a series of non-clinical bench tests and a comparative analysis of specifications to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Mechanical Integrity	Distal Fatigue Testing of worst-case stem/head configurations	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
	Proximal Fatigue Testing of worst-case stem/head configurations	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
	Porous Coating Bond Strength	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
	Modular Connection Pull-out Strength	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
	Modular Connection Fretting Corrosion	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
Biomechanical Design	Range of Motion analysis	Demonstrated to be as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
Material/Geometry	Material composition and strength requirements (for ZHS stems and 36mm head/insert components)	Same as or similar to predicate devices.
Functional Equivalence	Compatibility with Helicon Hip System components	All ZHS components are compatible with all HHS femoral heads, acetabular components, and cancellous bone screws.
Design Equivalence	Overall technological characteristics to predicate devices	Same or similar to predicate devices.

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

Sample Size for Test Set: Not explicitly stated in terms of a numerical sample size of devices tested. The testing involved "worst-case stem/head configurations," implying a selection of representative components that would experience the highest stresses or potential failure modes.
Data Provenance: The testing was "nonclinical bench testing" and involved a "Failure Modes and Effects Analysis (FMEA)." This indicates laboratory testing, rather than human clinical data. The data provenance is from the manufacturer's (or its licensee's) internal testing. Country of origin for the data is not specified beyond being generated for a U.S. FDA submission. The data is retrospective in the sense that it evaluates manufactured components against predefined criteria; it is not a prospective clinical trial.

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

This question is not applicable in the context of this device and documentation. "Ground truth" in this context refers to the defined engineering specifications and performance standards against which the device's mechanical properties were measured. These standards are established by engineering principles, regulatory guidelines (e.g., ISO standards for implants, not detailed here), and comparison to predicate devices, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process of resolving discrepancies among human readers in interpreting clinical data. For bench testing of mechanical properties, results are typically measured objectively against predefined engineering thresholds.

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, an MRMC comparative effectiveness study was not done. This document pertains to a hip implant (hardware), not an AI algorithm for diagnostic imaging or decision support. Therefore, there is no AI component or human reader performance to evaluate.

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 is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:
- Engineering Specifications and Performance Standards: Established mechanical testing methodologies (e.g., fatigue testing, bond strength, fretting corrosion, range of motion) used to ensure the device meets required functional and safety thresholds.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of legally marketed predicate devices. The ZENITH Hip System is shown to perform "at least as safely and effectively" as these predicates.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical hip implant. The principles of substantial equivalence and bench testing do not involve machine learning training sets.

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

This question is not applicable for the reasons stated in point 8.

Summary

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KI21636.

OCT 24 2012

2. 510(k) SUMMARY

Sponsor Name:	TGM Medical, Inc.5145 Golden Foothill Parkway, Suite 175El Dorado Hills, CA 95762
510(k) Contact:	Prakash PaiPhone: (916) 358-8835Cell: (774) 277-1312Email: Prakash.pai63@yahoo.com
Date Prepared:	Revised October 23, 2012 to support Supplement 1 and 2 basedon FDA AI requests for K121636 (August 15th, 2012 andSeptember 26, 2012)
Trade Name:	ZENITH Hip System
Common Name:	Hip prosthesis; porous coated and nonporous coated
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3358, Class II device,Product Code LPH).
	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR 888.3353, Class IIdevice Product Code LZO)

Device Description:

Page #1 24 3

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Attachment 1 of the September 12, 2012 Al response/Supplement 1 ). The 36mm inserts are offered in neutral or 10 degree hooded configurations. Hooded inserts include an X-ray marker manufactured from wrought Ti alloy. The 36mm heads and mating inserts are also compatible with the Helicon Hip System.

Indications for Use:

The ZENITH Hip System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
Proximal femoral fractures. ்.
D. Avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures. E.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

Substantial Equivalence:

Technological Characteristics/Substantial Equivalence:

Consensus Orthopedics, Inc. (COI) licensed two of their Consensus Hip System (CHS) femoral stem designs along with their CHS distal centralizer to TGM Medical for use as the ZHS femoral components. These CHS stem designs were modified from the predicate CHS stem components cleared under K935193 and K922561 to incorporate neck reliefs. The distal centralizer is identical to that cleared under K922561. All ZHS implant components are compatible with all HHS femoral heads, acetabular components, and cancellous bone screws cleared under K111472 (Consensus had licensed their TaperSet Hip to TGM for the HHS).

COI licensed the predicate CHS 36mm CoCr femoral head design cleared under K070061 and a mating 36mm UHMWPE insert design to TGM Medical for use as part of the ZHS. The ZHS 36mm heads are identical in material and geometry as the CHS 36mm CoCr heads cleared under K070061. The mating ZHS 36mm inserts are identical in geometry as the CHS 36mm inserts cleared under K070061. The ZHS 36mm inserts employ identical material and outer dome/locking mechanism geometry as the predicate HHS 32mm inserts. The ZHS 36mm head/insert components are compatible with all ZHS and HHS implant components of the appropriate size.

Because the subject ZHS stems and 36mm head/insert components employ the same material composition and strength requirements, have the same or similar technological

Page #2 28-3

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X171636

characteristics, and have similar indications as their predicate devices, the ZHS stems and 36mm head/insert components are substantially equivalent to legally marketed predicates (Table 2.1).

510(k)Number	Trade Name	510(k) holder	510(k)Clearance
K922561	Consensus Total Hip System	U.S. Medical Products, Inc.	07/21/1993*
K935193	Consensus Hip System - PorousCoated Titanium Femoral Stem	U.S. Medical Products, Inc.	08/18/1994*
K032396	RingLoc 36mm Liners and ModularFemoral Heads	Biomet, Inc.	08/21/2003
K070061	36mm CoCr Femoral Head and36mm [crosslinked] Acetabular Insert	Hayes Medical, Inc.	01/31/2007**
K060918	Excia Total Hip	Aesculap, Inc.	05/26/2006
K111472	Helicon Hip System	TGM Medical, Inc.	09/06/2011

Table 2.1: Legally marketed predicates to which substantial equivalence is claimed.

Notes: * Cleared prior to the purchase of U.S. Medical Products by Hayes Medical in 1996. ** Cleared prior to the change in company name from Hayes Medical to Consensus Orthopedics in 2008.

Non-Clinical Performance Data:

COl provided rights to reference their 510(k)s and supporting performance testing. The ZHS components were evaluated using a Failure Modes and Effects Analysis (FMEA). Nonclinical bench testing was carried out when geometry and/or material presented a new worstcase in comparison to predicate devices.

Bench testing included distal and proximal fatigue testing of the worst-case stem/head configurations, Range of Motion analysis, porous coating bond strength, and testing of the modular connection including pull-out and fretting corrosion. All of the observed results for the porous Ti and nonporous CoCr stem designs licensed to TGM medical demonstrate that the ZHS is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.

The 36mm head/insert components are proven through the use of predicate devices using the same head size, design, and material (K070061), the same mating insert size and design (K070061), and the same mating insert material composition (K032396). Therefore, no additional testing was deemed necessary over that used in support of the predicates based on identical design and materials.

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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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

TGM Medical, Incorporated % Mr. Prakash Pai Vice President, Global Quality and Regulatory Affairs 5145 Golden Foothill Parkway, Suite 175 El Dorado Hills, California 95762

Re: K121636

Trade/Device Name: ZENITH Hip System 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, LZO

Dated: October 16, 2012 Received: October 18, 2012

Dear Mr. Pai:

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

OCT 2 4 2012

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Page 2 - Mr. Prakash Pai

forth in the quality systems (OS) 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" (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,

ercly yours,

N. Melkerson

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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(171636

1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: ZENITH Hip System

Indications for Use:

The ZENITH Hip.System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic A. arthritis.
Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B.
Proximal femoral fractures. C.
Avascular necrosis of the femoral head. D.
Non-union of proximal femoral neck fractures. E.
Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, F. coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K121636

Page 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.