The Anato™ 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 stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.

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

Additional indication specific to use of Anato™ Hip Stem 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.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Device Description

Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.

The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.

The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study information based on the provided text, categorized as you requested.

The provided document describes a 510(k) premarket notification for a hip stem, which primarily relies on substantial equivalence to predicate devices rather than independent clinical efficacy studies. Therefore, many of the typical elements of AI/software device evaluation (like ground truth, expert consensus, MRMC studies, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Composition	Identical material combinations to predicate device (Accolade® II Hip Stem).	Made from titanium (Ti-6Al-4V) alloy, CP titanium coating, and PureFix® hydroxylapatite (HA) coating, identical to the previously cleared Accolade® II Hip Stem.
Design Characteristics	Similar design to ABG® II Monolithic stem (anatomic, 130-degree neck angle, normalization patterns).	Similar in design to ABG® II Monolithic stem; anatomic stem with a 130-degree neck angle and normalization patterns for press-fit stability and load transmission.
Mechanical Performance	Pass distal stem fatigue testing per ISO 7206-4.	Met compliance.
Mechanical Performance	Pass neck fatigue testing per ISO 7206-6.	Met compliance.
Intended Use	Consistent with predicate devices.	Alleviate pain and restore function in primary and revision total/hemi-hip arthroplasty; consistent with predicate indications.
Substantial Equivalence	Demonstrably equivalent in intended use, materials, and performance characteristics to predicate devices.	Device comparison and mechanical testing showed substantial equivalence to predicate devices (ABG® II Monolithic Hip Stem K110807, Accolade® II Hip Stem K103479, K120578).

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. The evaluation was based on non-clinical testing (mechanical fatigue) and comparison to predicate devices, not on a "test set" of clinical data.
Data Provenance: Not applicable for clinical data. For non-clinical testing, it would refer to the testing facilities and methods as described by ISO standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device relies on mechanical testing standards and comparison to predicate devices, not on expert consensus or ground truth derived from expert review of individual cases. Decisions on substantial equivalence are made by regulatory bodies based on submitted documentation.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the sense of clinical cases requiring adjudication. Mechanical test results are objective measurements against a standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This is a medical device (hip stem), not an AI or imaging diagnostic tool that would typically involve human readers.
Effect size of human readers with/without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical hip stem, not an algorithm or software. Its performance is evaluated through mechanical testing and material properties.

7. Type of Ground Truth Used

Mechanical Testing Standards and Predicate Device Performance Data: Performance was established against recognized international standards (ISO 7206-4 and ISO 7206-6) for mechanical fatigue, and by demonstrating identical material compositions and similar design characteristics to legally marketed predicate devices. The "ground truth" for substantial equivalence is the proven safety and effectiveness of the predicates and compliance with relevant engineering standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for it.

Summary

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

	510(k) Summary
Sponsor:	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person:	Colleen BurdelRegulatory Affairs Associatet. 201-831-5969f. 201-831-4969
Date Prepared:	November 20 , 2012
Proprietary Name:	ABG® III Monolithic Hip Stem (also known asAnato™ Hip Stem)
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR §888.3353 (Product Codes MAY, LZO, MEH)
	Hip joint metal/polymer/metal semi-constrainedporous coated uncemented prosthesis, 21 CFR§888.3358 (Product Codes LPH, MBL)
Legally Marketed Device to Which Substantial Equivalence is Claimed:ABG® II Monolithic Hip Stem	K110807

ABG® II Monolithic Hip Stem	K110807
Accolade® II Hip Stem	K103479, K120578

Device Description:

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

use with compatible Howmedica Osteonics' femoral heads and acetabular components.

Intended Use:

Indications:

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

Additional indication specific to use of Anato™ Hip Stem 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.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

Summary of Technologies:

Device comparison and mechanical testing showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.

Non-Clinical Testing:

The following tests were conducted:

1 ) Distal Stem Fatigue Testing in compliance with ISO 7206-4
1. Neck Fatigue Testing in compliance with ISO 7206-6

The results of the above testing verify that the new device is substantially equivalent to devices currently cleared for marketing.

Clinical Testing:

Clinical testing was not required as a basis for substantial equivalence.

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

Conclusion:

. .

. . . .

The Anato™ Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification.

. . . .

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

August 16, 2013

Ms. Colleen Burdel Regulatory Affairs Associate Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K123604

Trade/Device Name: ABG III Monolithic Hip Stem (also known as Anato™ 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: MAY. LZO, MEH, LPH, MBL Dated: July 15, 2013 Received: July 16, 2013

Dear Ms. Burdel:

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 10 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: CDRII 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

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

Page 2 – Ms. Colleen Burdel

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours,

Erin I. Keith

For

Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K123604

Device Name: ABG® III Monolithic Hip Stem (also known as Anato™ Hip Stem)

The indications for use for total hip arthroplasty include:

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

Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:

1. 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.
  The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR
Over-The-Counter Use
(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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.