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.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. 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.

Device Description

The subject devices represent sterile screws with additional lengths to allow surgeons more flexibility for the fixation of the acetabular augments, buttresses, and shims. Specifically, the lengths include 14-24mm in increments of 2mm and lengths 25-70mm in increments of 5mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the DePuy Gription® TF 5.5mm Sterile Locking Screws, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Device Performance (How the device met the criteria)
Material Equivalence	The device is made of TI-6AL-4V-ELI, which is the same material as the comparable screws of the predicate device (DePuy Universal Gription TF Cones and Acetabular Augment System 5.5mm Cancellous Locking, Non-Sterile Screws, K100391).
Head Geometry Equivalence	The device has a "Locking" head geometry, which is the same as the comparable screws of the predicate device.
Major Diameter Equivalence	The device has a major diameter of 5.5mm, which is the same as the comparable screws of the predicate device.
Functional Equivalence	"Push out testing of subject device screws" was performed to demonstrate that the expanded lengths maintain equivalent performance (implied by the conclusion of substantial equivalence).
Mechanical Strength/Integrity	"Print review" and "tolerance analysis" were conducted, indicating verification of design specifications and fit, which are critical for mechanical performance.
Substantial Equivalence to Predicate Device	Based on "print review, tolerance analysis, and push out testing," the non-clinical tests concluded that the subject device is substantially equivalent to the predicate device, implying it meets all performance aspects relevant for its intended use.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the test set.
- The data provenance is not explicitly stated. The tests conducted are "Print review, tolerance analysis, and push out testing of subject device screws," which are likely performed in a laboratory setting by the manufacturer (DePuy Orthopaedics, Inc.) in the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests seem to be engineering and mechanical performance tests rather than those requiring expert ground truth in a clinical sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. The tests mentioned are objective engineering tests rather than subjective assessments requiring adjudication.
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 MRMC study was conducted. This device is a medical screw, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical screw.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be engineering specifications, material properties, and mechanical test results (e.g., force required for push-out, dimensional tolerances). It's based on established engineering standards for medical devices of this type, rather than clinical outcomes or pathology.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a "training set." The development of the device would rely on engineering principles, design specifications, and manufacturing processes, rather than a data-driven training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The design and validation of the device rely on established engineering principles, material science, and manufacturing quality control.

Summary

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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
Phonenumber	(574) 371-4981
Fax number	(574) 371-4987
EstablishmentRegistrationNumber	1818910
Name ofcontactperson	Correne Ramy
Date prepared	February 25, 2013
Name of device
Trade orproprietaryname	DePuy Gription® TF 5.5mm Sterile Locking Screws
Common orusual name	5.5mm Sterile Locking Screws
Classificationname	Hip joint metal/polymer/metal, semi-constrained, porous-coated,uncemented prosthesisHip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesisHip 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 marketeddevice(s) to whichequivalence isclaimed	DePuy Universal Gription TF Acetabular Augment System (K100391,cleared September 29, 2010)
Reason for 510(k)submission	Line extension
Device description	The subject devices represent sterile screws with additional lengths toallow surgeons more flexibility for the fixation of the acetabular augments,buttresses, and shims. Specifically, the lengths include 14-24mm inincrements 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:1. 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 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® TF5.5mm Sterile LockingScrews	DePuy Universal Gription TF Cones andAcetabular Augment System 5.5mmCancellous Locking, Non-Sterile Screws[Comparable Screws](K100391)
Material	TI-6AL-4V-ELI	TI-6AL-4V-ELI
Head geometry	Locking	Locking
Lengths	14-24mm in 2mmincrements25-70mm in 5mmincrements	25-100mm in 5mm increments
Major diameter	5.5mm	5.5mm
Sterility	Sterile	Non-Sterile
Method ofSterilization	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 (800) 638-2041 or (301) 796-7100 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:

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

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

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.