DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS

K123924 · Depuy Orthopaedics · LZO · Mar 1, 2013 · Orthopedic

Device Facts

• Record ID: K123924
• Device Name: DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
• Applicant: Depuy Orthopaedics
• Product Code: LZO · Orthopedic
• Decision Date: Mar 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty

Device Story

DePuy Gription TF 5.5mm Sterile Locking Screws are orthopedic fixation components used in total hip arthroplasty. These screws provide mechanical fixation for acetabular augments, buttresses, and shims to the acetabular cup or bone. The device is a line extension of the predicate system, offering additional lengths (14-24mm in 2mm increments; 25-70mm in 5mm increments) to provide surgeons with increased flexibility during complex hip reconstruction procedures. The screws are manufactured from TI-6AL-4V-ELI titanium alloy and are provided sterile via gamma radiation. They are intended for use by orthopedic surgeons in a clinical/surgical setting to stabilize the acetabular construct, facilitating either cemented or cementless fixation. The output is a secure mechanical attachment, which aids in restoring joint stability and function for patients undergoing hip replacement.

Clinical Evidence

No clinical testing was required to demonstrate substantial equivalence. Evidence is based on non-clinical bench testing, including print review, tolerance analysis, and push-out testing.

Technological Characteristics

Material: TI-6AL-4V-ELI titanium alloy. Geometry: Locking head, 5.5mm major diameter. Lengths: 14-24mm (2mm increments) and 25-70mm (5mm increments). Sterilization: Gamma radiation. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or certain cases of ankylosis. Used with Pinnacle Acetabular Cup, Bantam Acetabular Cup, and Revision Acetabular Cup systems.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• DePuy Universal Gription TF Acetabular Augment System (K100391)

Submission Summary (Full Text)

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# K123924 (Page 1 of 3)

## Section 5: 510 (k) Summary

:

# MAR 0 1 2013

### (As required by 21 CFR 807.92 and 21 CFR 807.93)

| Submitter Information | | |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Orthopaedics, Inc. | |
| Address | 700 Orthopaedic Drive, Warsaw, Indiana 46582 | |
| Phone<br>number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration<br>Number | 1818910 | |
| Name of<br>contact<br>person | Correne Ramy | |
| Date prepared | February 25, 2013 | |
| Name of device | | |
| Trade or<br>proprietary<br>name | DePuy Gription® TF 5.5mm Sterile Locking Screws | |
| Common or<br>usual name | 5.5mm Sterile Locking Screws | |
| Classification<br>name | Hip joint metal/polymer/metal, semi-constrained, porous-coated,<br>uncemented prosthesis<br>Hip joint metal/ceramic/polymer semi-constrained cemented or non-<br>porous uncemented prosthesis<br>Hip joint metal/polymer, semi-constrained cemented prosthesis | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3358, 888.3353, and 888.3350 | |
| Product Code(s) | LPH, LZO, JDI | |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | DePuy Universal Gription TF Acetabular Augment System (K100391,<br>cleared September 29, 2010) | |
| Reason for 510(k)<br>submission | Line extension | |
| Device description | The subject devices represent sterile screws with additional lengths to<br>allow surgeons more flexibility for the fixation of the acetabular augments,<br>buttresses, and shims. Specifically, the lengths include 14-24mm in<br>increments of 2mm and lengths 25-70mm in increments of 5mm. | |
| Intended use of the device | Total hip arthroplasty | |
| Indications for use | Total hip replacement is indicated in the following conditions:<br>1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.<br>2. Avascular necrosis of the femoral head.<br>3. Acute traumatic fracture of the femoral head or neck.<br>4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.<br>5. Certain cases of ankylosis.<br><br>The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled augment/acetabular cup construct is intended for cemented or cementless use.<br><br>The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The Gription TF titanium buttress/shim is affixed to the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular cup construct is intended for cemented or cementless use. | |
| Summary of the technological characteristics of the device compared to the predicate device | | |
| Characteristic | DePuy Gription® TF<br>5.5mm Sterile Locking<br>Screws | DePuy Universal Gription TF Cones and<br>Acetabular Augment System 5.5mm<br>Cancellous Locking, Non-Sterile Screws<br>[Comparable Screws]<br>(K100391) |
| Material | TI-6AL-4V-ELI | TI-6AL-4V-ELI |
| Head geometry | Locking | Locking |
| Lengths | 14-24mm in 2mm<br>increments<br>25-70mm in 5mm<br>increments | 25-100mm in 5mm increments |
| Major diameter | 5.5mm | 5.5mm |
| Sterility | Sterile | Non-Sterile |
| Method of<br>Sterilization | Gamma radiation | None |

:

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# K123924 (Page 2 of 3)

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#### K123924 (Page 3 of 3)

#### PERFORMANCE DATA

### SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Print review, tolerance analysis, and push out testing of subject device screws

### SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical testing was required to demonstrate substantial equivalence.

#### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical testing support substantial equivalence of the subject device to the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

#### Public Health Service

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

March 1, 2013

DePuy Orthopaedics % Ms. Correne Ramy Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K123924

Trade/Device Name: DePuy Gription® TF 5.5mm Sterile Locking Screws Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LPH Dated: December 19, 2012 Received: December 20, 2012

Dear Ms. Ramy:

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

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#### Page 2 - Ms. Correne Ramy

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin >Keith

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

Enclosure

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# Section 4: Indications for Use Statement

### 510 (k) Number (if known): K123924

### Device Name: DePuy Gription® TF 5.5mm Sterile Locking Screws

#### Indications for Use:

The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use with the Pinnacle® Acetabular cup System, the Pinnacle® Bantam Acetabular Cup System and the Pinnacle® Revision Acetabular Cup System for total hip replacement in the following conditions:

- I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- 3. Acute traumatic fracture of the femoral head or neck.
- 4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled augment/acetabular cup construct is intended for cemented or cementless use. .

The porous Gription TF titanium shim is affixed to the mating bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The Gription TF titanium buttress/shim is affixed to the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Anton E. Dmitriev, PhD Division of Orthopedic Devices