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 Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is intended for single-use only.

AI/ML Overview

Here's an analysis of the provided text regarding the Klassic HD™ Offset Femoral Stem, focusing on the acceptance criteria and the study performed, structured according to your requested points:

The provided 510(k) summary for the Total Joint Orthopedics Klassic HD™ Offset Femoral Stem describes a medical device component, not a software or AI-driven diagnostic device. Therefore, the information typically requested for AI/ML device studies regarding ground truth, expert adjudication, MRMC studies, and training/test sets is not directly applicable in this context.

Instead, the "acceptance criteria" and "study" refer to bench testing to demonstrate the physical and mechanical performance of the femoral stem and its substantial equivalence to predicate devices. The primary goal is to show that the new design (with a different neck shaft angle and offset) performs as safely and effectively as existing, legally marketed devices.

Here's the breakdown based on the provided text, reinterpreting the questions for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength & Durability:
Neck Fatigue Resistance (no failure under specified loads)	Testing conducted, results cited as demonstrating equivalence
Stem Fatigue Resistance (no failure under specified loads)	Testing conducted, results cited as demonstrating equivalence
Modular Connection Integrity:
Axial Disassembly Resistance (maintains connection)	Evaluation conducted, results cited as demonstrating equivalence
Torsional Disassembly Resistance (maintains connection)	Evaluation conducted, results cited as demonstrating equivalence
Functional Range of Motion:
Appropriate Range of Motion for proper hip biomechanics	Determination conducted, results cited as demonstrating equivalence
Material Properties:
Identical Ti6Al4V material	Confirmed to be identical to predicate
Porous Coating Properties (for porous option):
Identical to predicate device's porous coating	Confirmed to be identical to Klassic HD Femoral Stem Porous

Note: The exact numerical acceptance criteria (e.g., specific load cycles for fatigue testing, exact force for disassembly) are not explicitly stated in this summary but are implicit by referring to industry guidance and ASTM standards. The reported performance is a general statement that the device meets these criteria and is equivalent to predicates.

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

This concept is not applicable as this is a physical medical device. The "test set" would refer to the number of physical samples of the femoral stem tested. The text does not specify the exact number of stems tested for each physical test (e.g., 5 stems for fatigue, 3 for disassembly).

Data Provenance: Not applicable in the sense of patient data. The "provenance" of the testing is non-clinical bench testing, conducted in a laboratory environment, guided by FDA guidance (e.g., "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses") and ASTM standards (e.g., "ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

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

Not applicable. "Ground truth" for a physical device like this is established through validated engineering tests following recognized standards, not by expert consensus on clinical data. The "experts" involved would be engineering and testing personnel, but their number and specific qualifications are not detailed beyond the general statement of following guidance and standards.

4. Adjudication Method for the Test Set

Not applicable. Test results for physical device characteristics are typically quantitative and objective (e.g., did it break or not, what was the force to disassemble). There is no "adjudication" in the sense of reconciling different expert opinions.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is based on:

Physical and Mechanical Performance Standards: Demonstrated by adherence to recognized national/international standards (e.g., ASTM F1814-97a) and FDA guidance for similar devices.
Comparison to Predicate Devices: The key "ground truth" here is the performance characteristics of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. There is no training set for this type of device.

Summary of the Study and Conclusion for the Klassic HD™ Offset Femoral Stem:

The study involved non-clinical bench testing on physical samples of the Klassic HD™ Offset Femoral Stem. These tests included:

Neck fatigue testing
Stem fatigue testing
Axial disassembly evaluation
Torsional disassembly evaluation
Range of motion determination

The testing was conducted based on established guidance from the FDA ("Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses, Document 1647 dated September 17, 2007") and ASTM standards ("ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

The objective of the study was to demonstrate that the Klassic HD™ Offset Femoral Stem is substantially equivalent to its predicate devices (Klassic HD Hip System, K100445, and Alloclassic Zweymuller SL Offset Femoral Stem, K033664) in terms of safety and efficacy. The conclusion drawn from these bench tests was that "All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices." This substantial equivalence determination was upheld by the FDA in their 510(k) clearance letter (K133832).

Summary

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510(k) SUMMARY

510(k) Notification K133832 (pg 1/3)

GENERAL INFORMATION

Applicant:

Total Joint Orthopedics, Inc. 1567 E Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 Fax: 801-486-6117

Contact Person:

Ben Casey Product Development Engineer Total Joint Orthopedics l 567 E. Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 FAX: 801-486-6117

Date Prepared: December 16, 2013

DEVICE INFORMATION

The Klassic HD™ Offset Femoral Stem is a modular femoral prosthesis to be used within the Klassic HD™ Hip System to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset in total hip arthroplasty.

Trade Name: Klassic HD™ Offset Femoral Stem

Generic/Common Name: Femoral Hip Stem

Classification:

21 CFR § 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Product Code: LPH, MBL, LWJ

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510(k) Summary

PREDICATE DEVICES

The Klassic HD Offset Femoral Stem is substantially equivalent in intended use, design, function and performance testing to the following predicate devices:

Klassic HD Hip System Total Joint Orthopedics K100445 .
Alloclassic Zweymuller SL Offset Femoral Stem Centerpulse . Orthopedics K033664

INTENDED USE

The Klassic HDTM 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 (ID): 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

TECHNOLOGICAL CHARACTERISTICS

The Offset Femoral Stem is a monolithic, titanium alloy, Zweymuller blade type stem featuring a neck shaft angle of 121° and increased lateral offset compared to the 131° neck shaft angle from the Klassic HD Femoral Stem. The Klassic HD Offset Femoral Stem utilizes the identical body geometry as the Klassic HD Femoral Stem, distal to the line of resection; along with the identical Ti6Al4V material and porous coated options.

The neck shaft angle of 121° and increased neck length are similar to the Alloclassic Zweymuller SL Offset Femoral Stem featuring a neck angle of 121° and 6.25mm increased lateral offset versus its predicate device.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Non-clinical testing was conducted on the Klassic HD Offset Femoral Stem to support a determination of substantial equivalence to the predicate devices. Non-clinical testing was based off of guidance from

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510(k) SUMMARY

Guidance for Industry and FDA Staff Non-clinical Information for . Femoral Stem Prostheses, Document 1647 dated September 17, 2007
. ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components

The performance testing for the Klassic HD Offset Femoral Stem consisted of neck and stem fatigue testing, axial and torsional disassembly evaluation and range of motion determination. The porous coating properties for the Klassic HD Offset Femoral Stem Porous are identical to that of the Klassic HD Femoral Stem Porous. All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices.

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Klassic HD Offset Femoral Stem. The Klassic HD Offset Femoral stem is similar to the predicate devices based on technological characteristics, design, non-clinical performance testing, material and intended use. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Klassic HD Offset Femoral Stem is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Public Health Service

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

March 13, 2014

Total Joint Orthopedics, Inc. Mr. Ben Casey Product Development Engineer 1567 E. Stratford Avenue Salt Lake City, Utah 84106

Re: K133832

Trade/Device Name: Klassic HD™ Offset Femoral Stem 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: December 16, 2013 Received: December 17, 2013

Dear Mr. Casey:

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 - Mr. Ben Casey

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

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™ OFFSET FEMORAL STEM 510(k) PREMARKET NOTIFICATION

SECTION 4 INDICATIONS FOR USE STATEMENT

K133832 (pg 1/1) 510(k) Number (if known):

Device Name: Klassic HDTM Offset Femoral Stem

Indications For Use:

The Klassic HDTM 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)

Elizabet旗峻Frank -S

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.