Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes surgical implants and screws, with no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes.
The device is described as "sterile screws with additional lengths to allow surgeons more flexibility for the fixation of the acetabular augments, buttresses, and shims" which are part of a total hip replacement system. Total hip replacement is a medical procedure used to treat severely painful and/or disabled joints, avascular necrosis, traumatic fractures, and failed previous hip surgeries, thus directly addressing and treating medical conditions.

Diagnostic

No

The device is an implantable component (augments, buttresses, and shims, along with screws for fixation) used in total hip replacement surgery, falling under the category of orthopedic surgical devices, not diagnostic tools.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is comprised of "sterile screws" and describes their physical characteristics (lengths and increments), indicating it is a hardware device. The intended use also describes physical components like "acetabular augments, buttresses and shims" and their fixation methods. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for total hip replacement surgery. It is a physical implant used to augment, buttress, or shim the acetabular cup.
Device Description: The device is described as sterile screws with additional lengths for fixation during surgery. This is a surgical implant component.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.
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.

Product codes (comma separated list FDA assigned to the subject device)

LPH, LZO, JDI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100391

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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
number	(574) 371-4981
Fax number	(574) 371-4987
Establishment
Registration
Number	1818910
Name of
contact
person	Correne Ramy
Date prepared	February 25, 2013
Name of device
Trade or
proprietary
name	DePuy Gription® TF 5.5mm Sterile Locking Screws
Common or
usual name	5.5mm Sterile Locking Screws
Classification
name	Hip joint metal/polymer/metal, semi-constrained, porous-coated,
uncemented prosthesis
Hip joint metal/ceramic/polymer semi-constrained cemented or non-
porous uncemented prosthesis
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
device(s) to which
equivalence is
claimed	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 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.
Intended use of the device	Total hip arthroplasty
Indications for use	Total hip replacement is indicated in the following conditions:

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

:

1

K123924 (Page 2 of 3)

2

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.

3

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

4

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

5

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.
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.

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