The ANTHOLOGY Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The ANTHOLOGY Hip Stem is for single use only.

Device Description

The ANTHOLOGY Hip Stem is manufactured from titanium alloy. The design of the stem is based upon the SYNERGY Hip Stem.

AI/ML Overview

The provided 510(k) summary for the ANTHOLOGY Hip Stem does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or comparison metrics.

Instead, this submission is a Premarket Notification (510(k)) which demonstrates substantial equivalence to a predicate device already legally marketed. For orthopedic implants like hip stems, substantial equivalence is typically established through a comparison of design features, material composition, intended use, and sometimes extensive bench testing and mechanical studies, rather than clinical efficacy studies with predefined acceptance criteria.

Here's how to address the requested information based on the provided text:

Acceptance Criteria and Device Performance

No specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative performance indicators) are reported in this 510(k) summary. The "acceptance criteria" for a 510(k) in this context is primarily demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The reported "device performance" relies on demonstrating substantial equivalence to the SYNERGY Hip Stem. This means the ANTHOLOGY Hip Stem is expected to perform similarly to the SYNERGY Hip Stem because of shared design, materials, and intended use. The "Design Control Activities" mentioned are internal processes to ensure the device meets its design specifications and is safe and effective, but the specific results or metrics are not detailed in this public summary.

Study Information (Based on Substantial Equivalence and lack of clinical trial)

Given that this is a 510(k) based on substantial equivalence, and no clinical performance study is described, most of the requested fields are not applicable or the information is not provided.

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Stated or Implied for 510(k))	Reported Device Performance
Substantial Equivalence to predicate device (SYNERGY Hip Stem) in:	"The intended use, design, and materials of the ANTHOLOGY Hip Stem are substantially equivalent to the SYNERGY Hip Stem."
* Design Features	"similarities in design features"
* Overall Indications	"overall indications"
* Material Composition	"material composition"
Safety and Effectiveness (implied through Design Control Activities)	"Design Control Activities have been completed and the results indicate that the subject device is safe and effective."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The summary does not describe a "test set" in the context of a performance study with human subjects or a dataset for AI. The "test set" here would refer to the characteristics of the ANTHOLOGY Hip Stem itself and its comparison to the predicate. Data provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment by experts is typically for diagnostic devices or AI algorithms, not for mechanical orthopedic implants demonstrating substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None specified. No adjudication method is described as there is no clinical performance test set.
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:
- No. This is an orthopedic implant, not an AI-assisted diagnostic device. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (hip stem), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. For this 510(k), the "ground truth" for substantial equivalence is the existing, legally marketed predicate device (SYNERGY Hip Stem) and its established safety and effectiveness. The ANTHOLOGY Hip Stem is deemed safe and effective if it performs as well as the predicate without raising new questions of safety or effectiveness.
The sample size for the training set:
- Not applicable / Not provided. No training set is described for a performance study.
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set is described.

In summary, this 510(k) submission establishes substantial equivalence through direct comparison to a predicate device, focusing on design, materials, and intended use. It does not involve clinical performance studies with specific acceptance criteria that would typically be described with metrics like sensitivity, specificity, or reader studies.

Summary

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K052792 //

OCT 7 - 2005 510(K) SUMMARY SMITH & NEPHEW ANTHOLOGY HIP STEM

SUBMITTER'S NAME:	Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-5778
CONTACT PERSON:	Katie Logerot
DATE SUMMARY PREPARED:	September 28, 2005
TRADE OR PROPRIETARY DEVICE NAME:	ANTHOLOGY Hip Stem
COMMON OR USUAL NAME:	Hip Stem
CLASSIFICATION NAME:	21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
DEVICE CLASS:	Class II
PRODUCT CODE:	Orthopedics/87/LPH, JDI, MEH, LZO

DEVICE INFORMATION:

INTENDED USE: A.

The ANTHOLOGY Hip Stem is for single use only.

DEVICE DESCRIPTION: B.

The ANTHOLOGY Hip Stem is manufactured from titanium alloy. The design of the stem is based upon the SYNERGY Hip Stem.

SUBSTANTIAL EQUIVALENCE INFORMATION: ﺯ

The substantial equivalence of the ANTHOLOGY Hip Stem is supported by its similarities in design features, overall indications, and material composition to the SYNERGY Hip Stem manufactured and distributed by Smith & Nephew, Inc.

SUMMARY OF TECHNOLOGICAL COMPARISON: D.

The intended use, design, and materials of the ANTHOLOGY Hip Stem are substantially equivalent to the SYNERGY Hip Stem. Design Control Activities have been completed and the results indicate that the subject device is safe and effective.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Katie Logerot Regulatory Affairs Specialist II Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis Tennessee 38116

Re: K052792

Trade/Device Name: ANTHOLOGY Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI, MEH, LZO Dated: September 29, 2005 Received: October 3, 2005

Dear Ms. Logerot:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire 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 not me 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); 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.

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Page 2-Ms. Logerot

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K052792 510(k) Number (if known):

Anthology Hip System Device Name:

Indications For Use:

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and mounnital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The ANTHOLOGY Hip Stem is for single use only.

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

Over-The-Counter Use
(21 CFR 801 Subpart C) No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices

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510(k) Number	K052792
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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.