noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
rheumatoid arthritis;
correction of functional deformity;
femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts.

Device Description

The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

AI/ML Overview

This submission (K121024) is a 510(k) premarket notification for a modification to the Instructions for Use (IFU) for several hip stem devices. The intent is to minimize the necessity for multiple IFUs and to update their content to reflect current practice.

Based on the provided document, there are no acceptance criteria or studies related to device performance in the context of AI/ML or diagnostic accuracy. This submission explicitly states "Non-Clinical Testing: None Provided" and "Clinical Testing: None provided."

The modifications relate to the labeling and administrative aspects of the device's usage instructions, not to any new or changed functional aspects that would require performance criteria or testing. The FDA's review in this case is focused on substantial equivalence to predicate devices based on indications, sterilization, and intended use, as documented on page 2.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types because these concepts are not applicable to the nature of this 510(k) submission.

Summary

{0}------------------------------------------------

K12/024

JUN 1 9 2012

Summary of Safety and Effectiveness

Date: March 23, 2012

Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758

Contact Person: William Garzon Regulatory Affairs Specialist Phone: (512) 834-6391 Fax: (512) 834-6313 Email: william.garzon@djoglobal.com

Product	510(k) Number, Clearance Date /Classification	ProductCode	Classification Name
Linear Porous Coated HipStem, Size 5	K991325 - June 25, 1999, ClassII	LPH	Hip joint metal/polymer/metal semi-constrained porous coated uncementedprosthesis per 21 CFR 888.3358
Revelation Hip Stem, Size8	K994070 - January 20, 2000,Class II	LPH	Hip joint metal/polymer/metal semi-constrained porous coated uncementedprosthesis per 21 CFR 888.3358
Foundation Porous PressFit Stem, Size 8	K991226 - June 1, 1999, ClassII	LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis per 21 CFR 888.3353
Foundation Cemented HipStem, Size 10.5 - 18	K952191 - July 17, 1995, ClassII	JDI,JDG	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3350
Foundation CementedStem, Size 8	K991227 - June 1, 1999, ClassII	JDI	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3350
Foundation CementedStem, Size 9	K961890 - June 14, 1996, ClassII	JDI	Hip joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3350

Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

Indications for Use: Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

The following Hip Stems are for Cementless application:

Linear Porous Coated Hip Stem, Size 5

Revelation Hip Stem, Size 8

Foundation Porous Press Fit Stem, Size 8

{1}------------------------------------------------

K12/024 Page 2/2

Summary of Safety and Effectiveness - cont. DJO Surgical Hip Systems

The following Hip Stems are for Cemented application: Foundation Cemented Hip Stem, Size 10.5 - 18 Foundation Cemented Stem, Size 8 Foundation Cemented Stem, Size 9

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, sterilization, and intended use.

Non-Clinical Testing: None Provided

Clinical Testing: None provided

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. 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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Encore Medical, L.P. % Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

JUN 1 9 2012

Re: K121024

Trade/Device Name: Linear Porous Coated Hip Stem, Size 5

Revelation Hip Stem, Size 8 Foundation Porous Press Fit Stem, Size 8 Foundation Cemented Hip Stem, Size 10.5 - 18 Foundation Cemented Stem, Size 8 Foundation Cemented Stem, Size 9

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, LZO, JDI, JDG Dated: March 27, 2012 Received: April 04, 2012

Dear Mr. William Garzon:

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.

{3}------------------------------------------------

Page 2 -- Mr. William Garzon

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.

Mark N. Mel

Sincerely yours,

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1/6

Device Name: Linear Porous Coated Hip Stem, Size 5

Indications for Use:

Linear Porous Coated Hip Stem, Size 5 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; �
correction of functional deformity: .
. femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ast

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121024

{5}------------------------------------------------

Page 2/6

Device Name: Revelation Hip Stem, Size 8

Indications for Use:

Revelation Hip Stem, Size 8 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
◆ rheumatoid arthritis;
correction of functional deformity;
femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asit

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

KIZIOLY

510(k) Number

{6}------------------------------------------------

Page 3/6

Device Name: Foundation Porous Press Fit Stem, Size 8

Indications for Use:

Foundation Porous Press Fit Stem. Size 8 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; ●
femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cementless mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashf

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

×121024 510(k) Number

{7}------------------------------------------------

Page 4/6

Device Name: Foundation Cemented Hip Stem, Size 10.5 - 18

Indications for Use:

Foundation Cemented Hip Stem, Size 10.5 - 18 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
rheumatoid arthritis; �
. correction of functional deformity;
. femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arsh

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

KILIO24 510(k) Number .

{8}------------------------------------------------

Page 5/6

Device Name: Foundation Cemented Stem, Size 8

Indications for Use:

Foundation Cemented Stem, Size 8 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
. rheumatoid arthritis;
. correction of functional deformity;
. femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ·

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ASnt

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K 121024 510(k) Number

{9}------------------------------------------------

Oze 6/6

Device Name: Foundation Cemented Stem, Size 9

Indications for Use:

Foundation Cemented Stem, Size 9 Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of ● the natural femoral head:
. rheumatoid arthritis;
correction of functional deformity: �
� femoral fracture:

This device may also be indicated in the salvage of previously failed surgical attempts. This stem is intended to be used in a cemented mode.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K|z|ozy

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.