The Klassic HD " Extended Offset Femoral Head, for use within the Klassic HD" Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. .
Those patients with failed previous surgery where pain, deformity or dysfunction . persists.
Revision of a previously failed hip arthroplasty. .
Patients who require a total hip replacement. ●

Device Description

The Klassic" HD Extended Offset Femoral Head is a modular component to be used within the Klassic HD™ Hip System (K100445). The Klassic HD™ Extended Offset Femoral Head is t used within the System as an optional prosthesis to the Klassic HD™ Femoral Head, a modular femoral head used within the Klassic HD™ Hip System. The Klassic HD™ Extended Offset Femoral Head features an offset bore and is composed of cobalt chromium and available in 32mm or 36mm diameters and available in -3.5mm, neutral, +3.5mm and +7mm head lengths. The Klassic HD " Extended Offset Femoral Head is to be used within the hip joint replacement system as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing leg length and offset.

AI/ML Overview

This 510(k) premarket notification describes a medical device, specifically a femoral head for hip replacement surgery, and focuses on demonstrating its substantial equivalence to previously approved devices rather than proving its performance against specific acceptance criteria through a traditional clinical study.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a device demonstrating substantial equivalence, there are no specific "acceptance criteria" for clinical performance in the way a new drug or novel AI algorithm would have. Instead, the "acceptance criteria" are implied by the performance of the legally marketed predicate devices, and the "reported device performance" refers to bench testing that shows the new device performs similarly or meets established engineering standards.

Acceptance Criteria (Implied by Predicate Devices & Engineering Standards)	Reported Device Performance (Klassic HD™ Extended Offset Femoral Head)
Mechanical Strength & Durability: Maintain structural integrity under physiological loads (e.g., fatigue resistance).	Successfully passed Fatigue Testing to demonstrate consistent performance during intended use.
Modular Connection Integrity: Secure and stable connection between components (e.g., ability to resist unintended disassembly).	Successfully passed Disassembly Testing to demonstrate consistent performance during intended use.
Biomechanical Functionality: Allow for appropriate range of motion.	Performance data for Range of Motion was provided to support substantial equivalence.
Material Compatibility: Biologically safe materials.	Passed Biocompatibility testing.
Sterility: Achieve and maintain sterility.	Passed Sterilization and cleaning validations.
Packaging & Stability: Maintain device integrity and sterility over time.	Passed Packaging and shelf life testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of clinical cases or patient data. The "test set" here refers to physical devices or component assemblies used in bench testing. The document does not provide the number of units tested for each non-clinical test (e.g., how many femoral heads were subjected to fatigue testing).
Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory bench testing conducted by the manufacturer, Total Joint Orthopedics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a physical device's mechanical properties is established through engineering specifications and industry standards, not by expert consensus on clinical cases. The tests are designed to measure physical properties.

4. Adjudication method for the test set

Not applicable. The "adjudication method" is not relevant for bench testing of physical device properties. The tests have predefined pass/fail criteria based on engineering standards.

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

Not applicable. This device is a physical hip implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant.

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

Not applicable. The device is a physical implant; there is no algorithm involved.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO, ASTM for medical devices), and the proven performance characteristics of legally marketed predicate devices. The non-clinical tests (fatigue, disassembly, range of motion, biocompatibility, sterilization, packaging) are designed to ensure the device meets these established physical and biological performance benchmarks.

8. The sample size for the training set

Not applicable. There is no AI algorithm or "training set" of data for this physical medical device. Device design and manufacturing processes are informed by engineering principles and safety standards, not machine learning training.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set."

Summary of the Study:

The study conducted for the Klassic HD™ Extended Offset Femoral Head was a series of non-clinical, bench-top tests. These tests were designed to demonstrate that the device's technological characteristics (material, design, function) are substantially equivalent to existing, legally marketed predicate devices. The objective was to show that the new device performs as intended and does not raise new questions of safety or effectiveness.

The specific tests performed included:

Fatigue Testing
Disassembly Testing
Range of Motion
Biocompatibility
Sterilization and cleaning validations
Packaging and shelf life

The study demonstrated that "the materials chosen, the manufacturing processes, and design of the Klassic HD™ Extended Offset Femoral Head meet the established specifications necessary for consistent performance during its intended use." This conclusion, supported by the collective results of the non-clinical testing, was sufficient for the FDA to determine substantial equivalence and clear the device for marketing.

Summary

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TOTAL JOINT ORTHOPEDICS, INC.

KLASSIC HD™ EXTENDED OFFSET FEMORAL HEAD 510(k) PREMARKET NOTIFICATION

510(k) SUMMARY

FEB 12 2014

510(k) Notification K131454

GENERAL INFORMATION

Applicant:

Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 U.S.A. Phone: 801-486-6070 FAX: 801-486-6117

Contact Person:

Jean M. Wheeler Product Development Engineer Total Joint Orthopedics 1567 E. Stratford Avenue Salt-Lake City, UT 84106 U.S.A. Phone: 801-486-6070 FAX: 801-486-6117

Date 510(k) Summary Prepared: February 10, 2014

DEVICE INFORMATION

Trade Name:

Klassic HD™ Extended Offset Femoral Head

Generic/Common Name:

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Classification:

21CFR$888.3358, Class II

Product Code:

LPH, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Prosthesis MBL, prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous LWJ, prosthesis, hip, semi-constrained, metal/polymer, uncemented

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Klassic HD™ Extended Offset Femoral Head 510(k) Premarket Notification

510(k) SUMMARY

PREDICATE DEVICE(S)

Total Joint Orthopedics Klassic HD™ Hip System (K100445) .
Accolade II Femoral Hip Stem, Howmedica Osteonics, Corp. (K103479) .
Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics (K033664) .
Modular Femoral Head with Offset Trunion, Kirschner Medical Corp (K914675) .

INDICATIONS FOR USE

The Klassic HD™ Extended Offset Femoral Head for use within the Klassic HD™ Hip System is intended for prosthetic replacement without bone cement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. .
Those patients with failed previous surgery where pain, deformity or dysfunction persists. .
Revision of a previously failed hip arthroplasty. .
. Patients who require a total hip replacement.

PRODUCT DESCRIPTION

The Klassic" HD Extended Offset Femoral Head is a modular component to be used within the
Klassic HD™ Hip System (K100445). The Klassic HD™ Extended Offset Femoral Head is t used within the System as an optional prosthesis to the Klassic HD™ Femoral Head, a modular femoral head used within the Klassic HD™ Hip System. The Klassic HD™ Extended Offset Femoral Head features an offset bore and is composed of cobalt chromium and available in 32mm or 36mm diameters and available in -3.5mm, neutral, +3.5mm and +7mm head lengths. The Klassic HD " Extended Offset Femoral Head is to be used within the hip joint replacement system as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing leg length and offset.

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Klassic HD™ Extended Offset Femoral Head 510(k) PREMARKET NOTIFICATION

510(k) SUMMARY

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Klassic HD™ Extended Offset Femoral Head are similar to the predicate devices in material, design and function. The Klassic HD" Extended Offset Femoral Head assembled with a modular femoral stem functions as a femoral component intended for total hip replacement. The device utilizes a functional neck and lateral offset which is substantially equivalent to the end geometry achieved by the modular femoral components of predicate devices. Performance data for fatigue testing of the assembled femoral component, modular disassembly properties and range of motion were provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the Klassic HD™ Extended Offset Femoral Head are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Klassic HD" Extended Offset Femoral Head is substantially equivalent to the predicate device.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on the Klassic HD" Extended Offset Femoral Head to support a determination of substantial equivalence to the predicate devices.

Nonclinical Testing Summary:

The nonclinical, bench testing included:

. Fatigue Testing
. Disassembly Testing
. Range of Motion
Biocompatibility .
Sterilization and cleaning validations .
Packaging and shelf life .

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Klassic HD" Extended Offset Femoral Head meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Klassic HD™ Extended Offset Femoral

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TOTAL JOINT ORTHOPEDICS, INC.

Klassic HD™ Extended Offset Femoral Head 510(k) PREMARKET NOTIFICATION

510(k) SUMMARY

Head does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices.

CONCLUSION

The results of the non-clinical testing verify that the Klassic HD™ Extended Offset Femoral Head functions as intended and exhibits the appropriate characteristics for total hip joint replacement. The Klassic HD™ Extended Offset Femoral Head has the same intended use and similar technological characteristics as those of the predicate devices. Furthermore, device safety and performance testing have demonstrated that the device performs as intended in its intended use environment. As such, the Klassic HD™ Extended Offset Femoral Head is substantially equivalent to the predicate devices in terms of technological characteristics, intended use and performance.

SUMMARY

The Klassic HD Extended Offset Femoral Head is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2014

Total Joint Orthopedics, Incorporated Ms. Jean Marie Wheeler Product Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106

Re: K131454

Trade/Device Name: Klassic HDTM Extended Offset Femoral Head 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, MBL, LWJ Dated: January 10, 2014 Received: January 13, 2014

Dear Ms. Wheeler:

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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and and a more of the bear Page 2 - Ms. Jean Marie Wheeler

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/ResourcesforYou/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,

Lori A. Wiggins

for

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

Enclosure

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TOTAL JOINT ORTHOPEDICS, INC.

Klassic HD™ Extended Offset Femoral Head 510(k) Premarket Notification

SECTION 4

: '

Indications for Use Statement

510(k) Number (if known): K131454

Device Name: Klassic HD™ Extended Offset Femoral Head

Indications For Use:

The Klassic HD " Extended Offset Femoral Head, for use within the Klassic HD" Hip System, is intended for prosthetic replacement without bone cement in treatment of the following:

Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. .
Those patients with failed previous surgery where pain, deformity or dysfunction . persists.
Revision of a previously failed hip arthroplasty. .
Patients who require a total hip replacement. ●

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ElizabethFDFrank-S

Divison 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.