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,
Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Device Description

The Accolade II Femoral Hip Stem, a tapered non-porous coated femoral stem intended for cementless, press-fit application. Accolade II has a variable medial curvature which increases with each stem size in order to facilitate press fit stability and load transmission in the proximal region of the stem geometry is designed to address variations in patient femoral morphology. The overall stem length has been reduced, compared to the Accolade TMZF hip stem, to facilitate intra-operative stem insertion.
The stem is manufactured from a Ti-6A1-4V substrate materially Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The Accolade II Femoral Hip Stem is available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. The Accolade II Femoral Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi hip arthroplasty to alleviate pain and restore function. The subject hip stem is compatible with V40 heads, C-taper heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.

AI/ML Overview

The provided text describes a 510(k) submission for the "Accolade II Hip Stem," which is a hip prosthesis. This submission is focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than showcasing performance against specific acceptance criteria through a clinical study.

Therefore, many of the questions related to acceptance criteria, device performance, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable in the context of this 510(k) summary. The FDA's 510(k) clearance process for devices like this typically relies on non-clinical testing (e.g., mechanical, material characterization) and comparison to predicate devices, rather than human clinical trials demonstrating a specific performance metric.

Here's how the provided information maps to your requests:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The submission states "Clinical testing was not required for this submission." The basis for clearance is demonstrating substantial equivalence to predicate devices through engineering and risk analysis, not meeting pre-defined performance acceptance criteria from a clinical study. The "performance" here refers to material and mechanical characteristics, which are implicitly acceptable if they match or are superior to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No clinical test set data was used. The evaluation was based on engineering and risk analysis compared to predicate devices.

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 clinical test set with expert-established ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication was used.

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. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a hip implant. Standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. As no clinical testing was performed to establish performance metrics, no ground truth as typically defined for clinical studies was established. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices based on their materials, design, and intended use, and the demonstration that the modified device is substantially equivalent to these predicates.

8. The sample size for the training set

Not Applicable. There was no "training set" in the context of machine learning or an AI algorithm. The device's design and materials were developed and evaluated through engineering principles.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K120578 (pg. 1 of 2)

MAR 2 9 2012

510(k) Summary of Safety and Effectiveness: Accolade II Hip Stem

Proprietary Name:	Accolade II Hip Stem
Common Name:	Hip Prosthesis
	Classification Name and Reference: Hip joint metal/ceramic/polymer semi-constrained or
	nonporous uncemented prosthesis, 21 CFR §888.3353
Proposed Regulatory Class:	Class II
Product Codes:	87MEH, 87LZO, 87LWJ, 87KWZ, 87KWY, 87KWL, 87JDI, 87LPH
For Information contact:	Valerie GiambancoRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6275 Fax: (201) 831-3275
Date Prenared:	2/17/2012

Description:

The stem is manufactured from a Ti-6A1-4V substrate materially Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The Accolade II Femoral Hip Stem is available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. The Accolade II Femoral Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi hip arthroplasty to alleviate pain and restore function. The subject hip stem is

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

K120578 (pg. 2 of 2)

compatible with V40 heads, C-taper heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.

Intended Use:

The modification does not alter the intended use of the predicate Accolade II system as cleared in the referenced premarket notifications.

Indications for Use:

The indications for use of the total hip replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

1. Rheumatoid arthritis
1. Correction of functional deformity;

Revision procedures where other treatments or devices have failed; and,
Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Devices for which Substantial Equivalence is claimed:

Howmedica Osteonics Accolade II System: K103479 .
Howmedica Osteonics Restoration Modular System: K013106 .
Howmedica Osteonics Accolade TMZF: K994366, K020572 & K023102 .

Proposed Modification:

The subject Accolade II Hip stems are compatible with additional acetabular components.

Summary of Technologies: Device comparison showed that the proposed expanded compatibility of the device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices. Engineering and risk analysis has been performed to demonstrate equivalence of the subject products to the predicate devices.

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Accolade II Hip Stems are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus.

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

Howmedica Osteonics % Ms. Valerie Giambanco Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

MAR 2 9 2012

Re: K120578 Trade/Device Name: Accolade II Hip Stem 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: MEH, LZO, LWJ, KWZ, KWY, KWL, JDI, LPH Dated: February 17, 2012 Received: February 28, 2012

Dear Ms. Giambanco:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Valerie Giambanco

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,

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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Special 510(k)

Accolade II

Indications for Use

510(k) Number (if known): _ K120578

Device Name: Accolade II Hip Stem

Indications for Use:

The indications for use of the total 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,
Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(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 (Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.