KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD

K131454 · Total Joint Orthopedics, Inc. · LPH · Feb 12, 2014 · Orthopedic

Device Facts

• Record ID: K131454
• Device Name: KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
• Applicant: Total Joint Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Klassic HD™ Extended Offset Femoral Head is a modular cobalt chromium prosthetic component for the Klassic HD™ Hip System. Features offset bore to assist surgeons in restoring hip joint biomechanics intraoperatively by independently addressing leg length and offset. Available in 32mm or 36mm diameters and four head lengths (-3.5mm, neutral, +3.5mm, +7mm). Used in total hip arthroplasty procedures; implanted by orthopedic surgeons in clinical settings. Device functions as a femoral component; provides mechanical stability and articulation within the hip joint. Benefits patients by correcting biomechanical deficits, reducing pain, and restoring function in cases of degenerative or inflammatory joint disease.

Clinical Evidence

Bench testing only. Testing included fatigue testing, disassembly testing, range of motion, biocompatibility, sterilization/cleaning validation, and packaging/shelf-life testing. Results demonstrate the device meets established specifications and performs as intended.

Technological Characteristics

Modular femoral head component; material: cobalt chromium; diameters: 32mm, 36mm; head lengths: -3.5mm, neutral, +3.5mm, +7mm; features offset bore for biomechanical adjustment; intended for uncemented use; mechanical assembly via modular trunnion interface.

Indications for Use

Indicated for patients requiring total hip replacement without bone cement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, or revision of failed hip arthroplasty.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

### Contact Person:

Jean M. Wheeler Product Development Engineer Total Joint Orthopedics 1567 E. Stratford Avenue Salt-Lake City, UT 84106 U.S.A. Phone: [phone] FAX: [phone]

### 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 [phone] or [phone] 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ElizabethFDFrank-S

Divison of Orthopedic Devices