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 Secur-Fit Advanced Hip 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.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Device Description

Howmedica Osteonics is introducing the Novel Fit and Fill Hip Stem (aka Secur-Fit Advanced), a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Secur-Fit Advanced is similar to other total hip stems that have been commercially distributed such as the Accolade II, Secur-Fit and Rejuvenate Monolithic Hip Stems. The Novel Fit and Fill and the Accolade II stem are both made from the same material combinations. The subject device is similar in design to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Three dimensional simulations have shown the normalizations on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in the proximal region of the femur. These normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The stem is manufactured from a Ti-6Al-4V substrate material, Commerically Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared Accolade II Hip Stem (K103479, K120578).

The Secur-Fit Advanced Hip Stem has a shot peened neck and includes 16 implant sizes 4-12 (nine 132° stems & seven 127° stems) that provide dual head offsets. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

AI/ML Overview

The provided document describes the K122853 510(k) submission for the Secur-Fit Advanced Hip Stem, which is a medical device. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in the manner one might find for a software or AI device.

Therefore, the requested information geared towards AI/software device studies (like sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission. This is a traditional mechanical medical device submission.

Here's the information derived from the document, tailored to the context of a mechanical medical device:

Acceptance Criteria and Device Performance (Mechanical Device)

Acceptance Criteria (Performance Requirement)	Reported Device Performance (Compliance)
Material Composition Equivalence	Manufactured from Ti-6Al-4V substrate, Commercially Pure (CP) Titanium coating, and Purefix hydroxylapatite (HA) coating, identical to previously cleared Accolade II Hip Stem (K103479, K120578).
Design Equivalence (General)	Similar in design to other commercially distributed total hip stems (e.g., Accolade II, Secur-Fit, Rejuvenate Monolithic Hip Stems).
Design Equivalence (Normalization Pattern)	Similar to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Has normalizations on anterior and posterior aspects of the proximal end.
Fatigue Strength (Distal Stem)	Passed Distal Stem Fatigue Testing in compliance with ISO 7206-4.
Fatigue Strength (Neck)	Passed Neck Fatigue Testing in compliance with ISO 7206-6.
Substantial Equivalence (Overall)	Demonstrated substantial equivalence based on mechanical testing, intended use, design, materials, and operational principles to predicate devices (Accolade II Hip Stem, Secur-Fit HA Hip, Rejuvenate Monolithic Hip Stem).

Study Details (Mechanical Device)

Sample size used for the test set and the data provenance:
- The document refers to "mechanical testing" (Distal Stem Fatigue Testing and Neck Fatigue Testing). For such tests, the "sample size" would typically refer to the number of physical device units tested according to the specified ISO standards. This specific number is not provided in the summary.
- Data provenance: Not explicitly stated, but mechanical testing is generally performed in a laboratory setting by the manufacturer or a contracted lab. This is standard pre-market testing for mechanical medical devices. It is not retrospective or prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical device testing, the "ground truth" is adherence to predefined engineering specifications and performance standards (e.g., ISO 7206-4, ISO 7206-6). Expert clinical consensus is not typically used to establish this type of ground truth.
Adjudication method for the test set:
- Not applicable. Test results are typically compared directly against the pass/fail criteria of the specified international standards. There is no "adjudication" in the sense of reconciling human reader opinions.
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 mechanical hip stem, not an AI or software device. MRMC studies are for assessment of reader performance, typically with imaging or diagnostic devices.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical hip stem, not an AI or software device.
The type of ground truth used:
- Compliance with international mechanical testing standards (ISO 7206-4 and ISO 7206-6) and demonstration of material and design equivalence to legally marketed predicate devices.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K122-853

510(k) Summary of Safety and Effectiveness FEB 1 2013
Proprietary Name:	Novel Fit and Fill Hip Stem (Secur-Fit Advanced)
Common Name:	Hip prosthesis
Classification Name and Reference:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR §888.3353
Regulatory Class:	Class II
Product Codes:	87 MEH - prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calcium-phosphate87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented87 LWJ - prosthesis, hip, semi-constrained,metal/polymer, uncemented87 KWZ - prosthesis, hip, constrained, cemented oruncemented, metal/polymer87 KWL - prosthesis, hip, hemi-, femoral, metal87 KWY - Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis87 JDI - prosthesis, hip, semi-constrained,metal/polymer, cemented87 LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented
For Information contact:	Valerie Giambanco, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6275 Fax: (201) 831-3275
Date Prepared:	January 8, 2013

Description:

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K122853

p.2/3

both made from the same material combinations. The subject device is similar in design to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Three dimensional simulations have shown the normalizations on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in the proximal region of the femur. These normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

Intended Use:

The Secur-Fit Advanced 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.

Indications:

Indications for use include:

Noninflammatory degenerative joint disease including osteoarthritis and avascular l ) necrosis;
1. Rheumatoid arthritis;
1. Correction of functional deformity:
Revision procedures where other treatments or devices have failed; and, 4)
ર) 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 Secur-Fit Advanced Hip 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.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

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K122 883

Substantial Equivalence:

The Secur-Fit Advanced Hip Stem is substantially equivalent to other commercially available hip stems in regard to intended use, design, materials and operational principles as a hip prosthesis. The following devices are examples of predicate systems: Accolade II Hip Stem, Secur-Fit HA Hip and Rejuvenate Monolithic Hip Stem. Based upon the mechanical testing, the Secur-Fit Advanced Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market.

Summary of Non-Clinical Testing:

The following tests were conducted on the subject device:

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

Neck Fatigue Testing in compliance with ISO 7206-6

The results of the above testing verify that the new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

February 1, 2013

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

Re: K122853

Trade/Device Name: Secur-Fit Advanced 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, KWL, KWY, JDI, LPH Dated: January 21, 2013

Received: January 23, 2013

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

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Page 2 - Ms. Valerie Giambanco. MS, RAC

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 (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 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. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K122853

Device Name: Secur-Fit Advanced

Indications for Use:

Indications for use 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Secur-Fit Advanced Hip 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.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Over-The-Counter Use Prescription Use X AND/OR (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)

Michael C. Owens

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.