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 Hip System is simple, easy to use, and based on clinically proven design philosophies. The Klassic HD Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version.

The Klassic HD Hip System is comprised of modular components with varying sizes available for each component for a cementless hip joint replacement application. Components of the Klassic HD Hip System include the femoral stem, femoral head, femoral head adapter sleeve, acetabular cup, acetabular insert and cancellous bone screws. The implantable components are intended for single-use for a single patient only.

The titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device called the "Klassic HD™ Hip System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through bench testing for mechanical performance, rather than clinical studies on human subjects. Therefore, many of the requested categories related to clinical study design, such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, and MRMC studies, are not applicable in this context.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating mechanical performance that is "substantially equivalent" to predicate devices, and in accordance with recognized standards for orthopedic implants. The reported performance is that the device "exhibit[s] the appropriate mechanical characteristics for total hip joint replacement."

Acceptance Criteria	Reported Device Performance
Performance equivalent to predicate devices for hip joint replacement.	"Results confirm that all components of the Klassic HD Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices."
Meets recognized standards for orthopedic implants (e.g., for proximal fatigue, distal fatigue, axial disassembly, torsional disassembly of femoral constructs; push-out, lever-out, torque to rotation of acetabular constructs; wear characteristics; static breaking strength and pull-out strength of cancellous bone screw; characterization of porous coating per FDA guidance).	"All testing was performed in accordance with recognized standards.""Performance data were provided to support the determination of substantial equivalence."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of physical test units, but the testing was "extensive bench testing" conducted on "the worst case femoral constructs" and "the worst case acetabular constructs" and "the worst case cancellous bone screw." This implies a selection of representatives for the most challenging use conditions.
- Data Provenance: The study was a bench test (laboratory testing) of the physical device components. There is no human or patient data involved. Therefore, country of origin is not applicable in the typical sense; the testing was performed to U.S. FDA standards as part of a 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for bench testing of mechanical properties is established by engineering standards and measurement techniques, not by expert medical opinion or consensus. The "truth" is the physical measurement of the device's performance against predefined engineering specifications.
Adjudication method for the test set:
- Not Applicable. As this was a bench test evaluating mechanical properties, there was no need for adjudication as typically understood in clinical studies (e.g., resolving discrepancies in expert interpretations). The results are objective physical measurements.
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. This was a premarket notification for a physical orthopedic implant, not a diagnostic or AI-driven decision support system. Therefore, MRMC studies and AI-related effectiveness are Not Applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 4. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was engineering specifications and recognized standards for orthopedic implant mechanical performance. The device's performance was compared to these established benchmarks and to the performance of predicate devices.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device itself is the product being tested, not an algorithm being trained.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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TOTAL JOINT ORTHOPEDICS, INC.

KLASSIC HD™ HIP SYSTEM 510(k) PREMARKET NOTIFICATION

510(k) Summary

510(k) Notification K100445

GENERAL INFORMATION

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

Contact Person:

Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive Suite 210 Sunnyvale, CA 94089 Phone: 408-400-0856 Fax: 408-400-0865

Date Prepared: October 22, 2010

DEVICE INFORMATION

The Klassic HD™ Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version.

Classification:

21 CFR§888.3358, Class II

Product Code:

LPH, MBL, LWJ

Trade Name:

Klassic HD™ Hip System

Generic/Common Name:

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

DEC - 3 2010

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510(k) SUMMARY (CONT.)

PREDICATE DEVICES

Accelerated Innovation, L.L.C., Accin™ Hip System (K073068) .
Centerpulse Orthopedics Ltd., Alloclassic" Zweymueller" SL/SLL Femoral Stem . (K030373)
Encore Orthopedics, Inc., Foundation® Porous Hip Stem (K991226) .
Howmedica Osteonics Corp., V-40" /C-Taper Adapter Sleeve (K051737) .
Encore Medical, L.P., Biolox® delta Ceramic Femoral Head and Biolox® delta . Ceramic Femoral Offset Sleeve (K082844)
Encore Medical, L.P., Foundation® Porous Coated (FMP™) Acetabular Shells . (K072888)
Smith & Nephew, Inc., R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners . (K092386)
Apex Surgical, LLC, Apex Modular™ Acetabular Cup (K031110) .
OMNI Life Science, Inc., Apex HCLATM Acetabular Cup Liners (K062489) .
OMNI Life Science, Inc., ApeX-LNK Poly™ Acetabular Cup Liners (K073150) .

INDICATIONS FOR USE

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 titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths

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510(k) Summary (Cont.)

of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Klassic HD Hip System are similar to the predicate devices. Performance data were provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The indications for use for the Klassic HD Hip System 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 Hip System is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Extensive bench testing was conducted on the Klassic HD Hip System to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Performance testing conducted for the worst case femoral constructs addressed proximal fatigue, distal fatigue, axial disassembly and torsional disassembly. Performance testing conducted for the worst case acetabular constructs included push-out, lever-out and torque to rotation testing as well as an evaluation of wear characteristics of the insert materials. The static breaking strength and the pull-out strength of the worst case cancellous bone screw were also assessed. The porous coating was characterized per FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Opposing Bone or Bone Cement" dated April 28, 1994.

All testing was performed in accordance with recognized standards. Results confirm that all components of the Klassic HD Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices.

SUMMARY

The Klassic HD Hip System 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 seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

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

Total Joint Orthopedics, Inc. % Mr. Kit Cariquitan Vice President, Regulatory Affairs Regulatory Consultant for Total Joint Orthopedics, Inc. Experien Group, LLC 155-A Moffett Park Drive Suite 210 Sunnyvale, California 94089

DEC - 3 2010

Re: K100445 Trade/Device Name: Klassic HD™ 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, MBL, LWJ Dated: October 22, 2010 Received: October 25, 2010

Dear Mr. Cariquitan:

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.

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Page 2 - Mr. Kit Cariquitan

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 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 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,

Mark N Milken

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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TOTAL JOINT ORTHOPEDICS, INC.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K100445

Device Name: Klassic HD™ Hip System

DEC. - 3. 2010

Indications for Use:

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)

Onetu for mxn
(Division Sign off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100445

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.