Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
Previously failed hip surgery.
Proximal femoral neck fractures or dislocation.
Idiopathic avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures.
Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

Device Description

Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating. The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

AI/ML Overview

This document describes the Entrada™ Hip Stem, a hip arthroplasty device, and its acceptance criteria for substantial equivalence to legally marketed predicate devices. The information provided is from a 510(k) Premarket Notification to the FDA.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

Unfortunately, the provided document does not explicitly state specific numerical acceptance criteria for the mechanical tests. It only lists the types of tests performed and generally concludes that the device "met the predetermined acceptance criteria" and that "The mechanical test results demonstrate that Entrada™ hip stem is safe and effective."

Test Type	Acceptance Criteria (Not explicitly stated with numerical values)	Reported Device Performance
Proximal fatigue	Implied to meet safety and effectiveness standards	Met predetermined criteria
Distal fatigue	Implied to meet safety and effectiveness standards	Met predetermined criteria
Range of motion	Implied to meet safety and effectiveness standards	Met predetermined criteria
Bacterial endotoxin	Met predetermined acceptance criteria (LAL pyrogen testing)	Met predetermined criteria

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that mechanical tests were "conducted on the worst-case configurations of Entrada™ hip stem." However, it does not specify the numerical sample size for these tests (e.g., number of stems tested for fatigue).
- Data Provenance: This was a non-clinical study involving mechanical testing of the device itself. Therefore, concepts like country of origin for patient data or retrospective/prospective clinical data do not apply. The data was generated in a laboratory setting.
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)

This question is not applicable as the studies performed were non-clinical mechanical tests, not clinical studies requiring expert ground truth for interpretation of patient data. The "ground truth" for mechanical testing is adherence to established engineering standards and performance targets.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there were no clinical studies or human interpretation of diagnostic data that would require an adjudication method.
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

This question is not applicable. No clinical studies, and specifically no MRMC studies involving human readers or AI assistance, were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a physical hip stem, not an algorithm or AI software. Therefore, there is no standalone algorithm performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical mechanical tests, the "ground truth" is based on established engineering standards, biomechanical principles, and the performance characteristics of predicate devices. The tests aim to demonstrate that the Entrada™ Hip Stem meets performance criteria consistent with devices already on the market and considered safe and effective.
The sample size for the training set

This question is not applicable. As this device is a physical hip stem and the studies were non-clinical mechanical tests, there is no concept of a "training set" like there would be for an AI algorithm.
How the ground truth for the training set was established

This question is not applicable for the same reasons as point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

August 24, 2017

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

Ortho Development Corporation Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020

Re: K171249

Trade/Device Name: Entrada™ 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, KWY, KWL Dated: July 25, 2017 Received: July 27, 2017

Dear Drew Weaver:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,

Katherine D. Kavlock -S

for

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) K171249

Device Name Entrada™ hip stem

Indications for Use (Describe)

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of the femoral head.
1. Non-union of proximal femoral neck fractures.
1. Treatment of fractures that are unmanageable using other forms of therapy.

Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5 510(k) Summary

Name of Sponsor:	Ortho Development® Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Drew WeaverDirector of Quality Assurance and Regulatory AffairsTelephone: (801) 619-3419Facsimile: (801) 553-9993DWeaver@orthodevelopment.com
Date Prepared:	August 21, 2017
Proprietary Name:	Entrada™ hip stem
Common Name:	Hydroxyapatite coated hip prosthesis
Classification:	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
Device Product Code:	MEH, LZO, KWY, KWL
Class:	Class II
Primary Predicate Device:	Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991)
Secondary Predicate Device(s):	Ortho Development® Ovation Tribute (K133386)Exactech Novation Element (K153649)

Description:

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Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating.

The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Indications:

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post-traumatic arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of the femoral head.
1. Non-union of proximal femoral neck fractures.
1. Treatment of fractures that are unmanageable using other forms of therapy.
1. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Basis for Substantial Equivalence:

Entrada™ hip stem has the same technological characteristics as the predicate devices. These include:

1. Indications for use
1. Basic design
1. Material
1. Sizes

The following non-clinical mechanical tests were conducted on the worst-case configurations of Entrada™ hip stem:

1. Proximal fatigue
1. Distal fatigue
1. Range of motion analysis

Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria.

Therefore the fundamental scientific technology of Entrada™ hip stem is the same as previously cleared devices. The mechanical test results demonstrate that Entrada™ hip stem is safe and effective. No clinical studies were performed.

Conclusions:

Based on similarities in intended use, design, materials, manufacturing methods, packaging, and the mechanical test results, the Entrada™ hip stem is substantially equivalent to the previously cleared predicate 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.