Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

Device Description

This 510/k) submission seeks FDA clearance to have the calcium phosphate coating (plasma sprayed from hydroxyapatite (HA) powder) on the subject hip components applied by an alternate coating supplier. The calcium phosphate coating is referred to as "HA coating." The hip system components included in this premarket notification are:

. Porous Synergy Hip Stems
. Non-Porous Synergy Stems
Porous Anthology Hip Stems .
. Porous Reflection Acetabular Shells

The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K002996 and K970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K990666 and K022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not change as a result of the implementation of an alternate HA coating supplier.

AI/ML Overview

The provided document is a 510(k) summary for a medical device seeking FDA clearance. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than establishing de novo safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested elements regarding acceptance criteria, study design, statistical details, and ground truth establishment are not applicable or available in this type of regulatory submission. The document primarily describes how the new HA coating supplier's product matches the characteristics and performance of the predicate device's coating.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to the successful demonstration of substantial equivalence to predicate devices. This is achieved by showing that the new HA coating produced by the alternate supplier is chemically and physically comparable to the original, and that the HA-coated components maintain the equivalent performance characteristics.

Acceptance Criteria (Implied by Substantial Equivalence for Medical Devices)	Reported Device Performance
Material Characterization of HA Coating:	All characterization parameters (composition, crystallinity, etc.) on the starting HA powders and final HA coating were provided and reviewed. NIST SRM 2910
Porous Coating Characterization (Pre-HA):	The sintered, metallic beaded porous coatings (prior to HA application) were characterized per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The results were acceptable.
Dual Coating Characterization (HA on Porous):	Additional characterization was performed to demonstrate that the definition of porosity (per 21 CFR 888.3358) was met for the dual coating of calcium phosphate on the metallic, sintered beaded coatings. The results were acceptable.
Maintenance of Design, Material, and Indications:	The design, principle of operation, type of substrate materials, dimensional characteristics, and indications for use remain unchanged from the predicate devices.
Overall Substantial Equivalence:	"All of the observed results indicate that the Smith & Nephew Hip Systems with HA are substantially equivalent to devices currently cleared for market."

Study Details (Applicable to 510(k) Substantial Equivalence, Not Clinical Studies)

Sample size used for the test set and the data provenance:
- Test Set: Not a traditional "test set" in the sense of clinical samples. The "test set" here refers to the actual device components and HA coating samples produced by the alternate supplier, which were subjected to various material and coating characterization tests. The specific number of samples for each test (e.g., how many HA powder lots, how many coated implants) is not specified in this summary.
- Data Provenance: The tests were conducted on components manufactured by Smith & Nephew using the alternate HA coating supplier. The testing described appears to be laboratory-based (e.g., material characterization, physical property testing), not clinical data from patients. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject HA coated devices."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on objective material and physical property testing, not expert interpretation of results to establish "ground truth" in a diagnostic sense. The "ground truth" (or benchmark) for comparison was the characteristics of the predicate device's HA coating and accepted industry standards/guidance documents.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for interpreting subjective data (e.g., image reads, clinical endpoints). The data here are quantitative material and coating characteristics, which are objectively measured and compared to predefined specifications or predicate device characteristics.
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 is a hardware/material modification submission, not an AI/software device. No human reader studies were conducted or are relevant to this type of device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware/material modification submission, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence was a combination of:
  - Specifications and characteristics of the legally marketed predicate devices.
  - Relevant guidance documents (e.g., "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants," "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement").
  - Industry standards and established test methods (e.g., comparing to NIST SRM 2910|a) for certain parameters).
  - Regulatory definitions (e.g., 21 CFR 888.3358 for porosity).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for the device would be the manufacturing process development and quality control of the alternate coating supplier.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the AI sense was used. The manufacturing process for the HA coating would have established its own internal quality control standards and specifications based on the desired material properties comparable to the predicate device.

Summary

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K090982

Summary of Safety and Effectiveness Smith & Nephew Hip Systems with HA

Date of Summary: April 19, 2010

Contact Person and Address:

Gino Rouss, MS Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-6707

APR 2 1 2010

Name of Device:	Smith & Nephew Hip Systems with HA
Common Name:	Hip System
Device Classification:	CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis ">– Class II
Device Product Codes:	MEH, LPH, LWJ, and LZO

Device Description

. Porous Synergy Hip Stems
. Non-Porous Synergy Stems
Porous Anthology Hip Stems .
. Porous Reflection Acetabular Shells

Performance Data

Summary reports which describe how the applicable guidance documents were used during device development and testing to address risks associated with the subject devices have been reviewed. The subject HA coating underwent characterization per the "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants." All characterization parameters on the starting powders and final coating were provided. In addition, the NIST SRM 2910|a) material was used as a comparator for X-ray diffraction, dissolution rate and solubility product parameters. Prior to being HA coated, the sintered, metallic beaded porous coatings were characterized per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The dual coatings of calcium phosphate coating on the metallic, sintered beaded coatings underwent additional characterization to demonstrate that the definition of porosity was met per 21 CFR 888.3358.

All of the observed results indicate that the Smith & Nephew Hip Systems with HA are substantially equivalent to devices currently cleared for market.

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Intended Use

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of traumatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Smith & Nephew Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

Technological Characteristics

Although the technological characteristics of the HA coating that will be applied using a plasma spray technique may be considered the same as the predicate HA coating, performance data was provided in support of substantial equivalence. The subject 510(k) includes implant devices that contain HA coating applied to a gritblasted titanium substrate and a -45/+60 mesh size CpTi porous bead coating.

Clinical data was not needed to support the safety and effectiveness of the subject HA coated devices.

Substantial Equivalence Information

The Smith & Nephew Hip Systems with HA are similar in overall design, material and indications to the Smith & Nephew Hip Systems with HA cleared via 510(k) Premarket Notifications K052792, K002996, K970337, K990666, and K022556.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

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

APR 2 1 2010

Smith & Nephew, Inc. % Mr. Gino Rouss, M.S. Manager, Regulatory Affairs Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K090982

Trade/Device Name: Smith & Nephew Hip Systems with HA Coating 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, LPH, LWJ, LZO Dated: April 19, 2010

Received: April 20, 2010

Dear Mr. Rouss:

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. Iisting 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 mav 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

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Page 2 - Mr. Gino Rouss, M.S.

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.

Sincerely yours,

Mark N. Melkers 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): K090982

Device Name: Smith & Nephew Hip Systems with HA

Indications for Use:

Smith & Nephew Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Snette
(Division Sign-Off) for mkn

Division of Surgical, Orthopedica and Restorative Devices

510(k) Number K090982

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.