The hip system devices included in this submission are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

The overall indications for use for the subject total and hemi hip replacement prostheses include:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Rejuvenate Hip System is intended for cementless use only.

Additional indications specific to the Hipstar Stem:
The Hipstar Femoral Stem is intended for cementless use only.

When mated with a constrained acetabular liner the Hipstar Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Additional indications specific to the Restoration Modular Hip System:
The Restoration Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Device Description

The devices included in this submission are femoral heads, acetabular shells, acetabular inserts, modular necks, modular stems and accessory components used in hip arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior 510(k) submissions and are commercially available. The purpose of this submission is to modify the labeling of these devices to include safety information in the Instructions for Use (IFUs) regarding modular hip stem junctions. In addition to this specific update, general revisions have been made to the IFUs to harmonize the language between the Howmedica Osteonics' hip stem labeling

AI/ML Overview

This K121308 submission is for a modification to the labeling of existing hip system devices, not for a new device requiring performance testing against specific acceptance criteria. The submission states: "The subject hip system devices have been deemed substantially equivalent to other commercially available hip arthroplasty systems based upon an evaluation of intended use, design, materials, and operational principles in prior 510(k) submissions. The purpose of this submission is solely to revise the labeling to add safety information regarding modular hip stem taper junctions."

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them is not applicable to this specific 510(k) submission.

To address the prompt directly based on the provided text, the relevant section is "Substantial Equivalence," which implies that the performance of the device has already been established and accepted in prior submissions.

Here's a breakdown of why the requested information cannot be provided from the given document:

1. A table of acceptance criteria and the reported device performance: Not applicable. This submission is for a labeling change, not a new device requiring performance criteria to be met. The substantial equivalence is based on prior 510(k)s.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No performance study data is presented in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No performance study data where ground truth is established is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study requiring adjudication is presented.
5. 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: Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established for this submission.
8. The sample size for the training set: Not applicable. No AI/machine learning training set is relevant to this device.
9. How the ground truth for the training set was established: Not applicable. No AI/machine learning training set is relevant to this device.

Conclusion based on the provided text:

The device's performance and acceptance criteria were established in previous 510(k) submissions, which deemed them "substantially equivalent to other commercially available hip arthroplasty systems based upon an evaluation of intended use, design, materials, and operational principles." This specific submission (K121308) does not provide details on the acceptance criteria or a study proving those criteria are met, as its sole purpose is to "revise the labeling to add safety information regarding modular hip stem taper junctions."

Summary

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K121308 (pg 1/3)

510(k) Summary

Hip Systems

JUL 30 2012

Proprietary Name:

Common Name:

Classification Names And References:

Artificial Hip Replacement Components -Acetabular and Femoral

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis21 CFR §888.3358

Hip joint metal/polymer constrained cemented or uncemented prosthesis.21 CFR §888.3310

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR §888.3353

Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR $888.3350

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3360

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis 21 CFR §888.3390

Proposed Regulatory Class: Class II

Product Codes:

LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer

LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

MEH - prosthesis, hip. semi-constrained. uncemented. metal/polymer, non-porous

JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented

LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented

KWL - prosthesis, hip, hemi-, femoral, metal

MAY - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

MBL- prosthesis, hip. semi-constrained, uncemented, metal/polymer, porous

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K121308 (pg 2/3)

For Information contact:

Karen Ariemma, RAC Senior Strategic Regulatory Affairs Manager Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-5718 Fax: (201) 831-4718

Date Prepared:

July 29, 2012

Description:

Intended Use:

The hip system devices included in this submission are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function.

Indications:

The overall indications for use for the subject total and hemi hip replacement prostheses include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
1. rheumatoid arthritis:
correction of functional deformity; 3.
1. revision procedures where other treatments or devices have failed; and,
1. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Rejuvenate Hip System is intended for cementless use only.

Additional indications specific to the Hipstar Stem:

The Hipstar Femoral Stem is intended for cementless use only.

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K121308(pg 3/3)

Additional indications specific to the Restoration Modular Hip System:

The Restoration Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Substantial Equivalence:

The subject hip system devices have been deemed substantially equivalent to other commercially available hip arthroplasty systems based upon an evaluation of intended use, design, materials, and operational principles in prior 510(k) submissions. The purpose of this submission is solely to revise the labeling to add safety information regarding modular hip stem taper junctions.

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

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines representing the body and a single line representing the head.

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

JUL 30 2012

Howmedica Osteonics Corp. % Ms. Karen Ariemma Senior Strategic Regulatory Affairs Manager 325 Corporate Drive Mahwah, New Jersey 07430

Re: K121308

Trade/Device Name: Hip Systems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Regulatory Classi Class Class 22, LZO, MEH, JDI, LWJ, KWL, MAY, KWY, MBL Dated: April 30, 2012 Received: May 1, 2012

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) (o regars) to regard) (and in the Medical Device Amendments, or to conninered phor to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (Act) that to nev request to the general controls provisions of the Act. The r ou may, merciole, market the device, occurements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and devices, good mananataring practices, and evaluate information related to contract liability adulteration. Ticase note: "ODIC assess 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 If your device is classified (See above) into ting major regulations affecting your device can be filly be subject to additional controls. "Enological of the 200 to 898. In addition, FDA may found in the Code of I cacrai resguing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a bacession with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination as administered by other Federal agencies. You must

{4}------------------------------------------------

Page 2 – Ms. Karen Ariemma

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 Of it Fart 607); accemes (21 CFR 803); good manufacturing practice requirements as set de rior related davers over (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 11 Jou atttp://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 note to 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 I ou may oounn other geficitional 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.lftm.

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K121308 (pg 1/1)

Device Name: Stryker Hip Systems

Indications for Use:

The overall indications for use for the subject total and hemi hip replacement prostheses include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
1. rheumatoid arthritis;
correction of functional deformity; 3.
revision procedures where other treatments or devices have failed; and, 4.
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ડ. with head involvement that are unmanageable using other techniques.

The Rejuvenate Hip System is intended for cementless use only.

Additional indications specific to the Hipstar Stem:

The Hipstar Femoral Stem is intended for cementless use only.

When mated with a constrained acetabular liner the Hipstar Stem is indicated for use in primary w len nialed with a combroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Additional indications specific to the Restoration Modular Hip System:

(Division Sign-Oft)

Division of Surgical, Orthopedic, and Restorative Devices

Over-The-Counter Use X Prescription Use ANDAPO(k) Number LCFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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.