The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and acetabular portions of the hip that are severely disabled and/or very painful as a result of:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis or traumatic arthritis
· Correction of functional deformity
· Non-union femoral neck fracture
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Device Description

The present 510k The Progressive Orthopaedic additional screw sizes and apical hole plug are components to be used with the Progressive Orthopaedic Total Hip System, previously cleared via K143314.

Screw Sizes	6.5mm OD x 15-45mm Length
Material	Ti6Al4V per ASTM 1472
Apical Hole Plug OD	Ø 8.52mm OD
Apical Hole Plug Thread	5/16 X 24 UNF 2A
Material	Ti6Al4V

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically "The Progressive Orthopaedic Total Hip System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies. Therefore, the information you've requested regarding acceptance criteria, study details, and expert opinions for clinical performance is largely not applicable or not present in this document, as clinical testing was not required for this submission.

Here's a breakdown based on the provided text, addressing your points where possible and noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Mechanical characterization	Equivalent to predicate devices
Torsion Resistance	Equivalent to predicate devices
Driving Torque	Equivalent to predicate devices
Pull Out Strength	Equivalent to predicate devices
Material Equivalence	Equivalent to predicate devices
Construction Equivalence	Equivalent to predicate devices
Performance Characteristics Equivalence	Equivalent to predicate devices

Explanation:
The document states under "Non-Clinical Testing": "Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, torsion, driving torque and pull out. In all testing, the subject device shows equivalent properties when compared to predicate products." It further elaborates: "Testing has determined that the device is substantially equivalent to the predicate device in material, construction, and performance characteristics."

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

Sample Size: Not specified in the document. Mechanical tests typically use a certain number of samples for each test type (e.g., torsion, pull-out), but these numbers are not detailed here.
Data Provenance: Not specified, but generally, non-clinical bench testing data would be generated in a lab setting by the device manufacturer or a contract research organization. It would be prospective to the submission.

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

Not Applicable. This document pertains to mechanical and material equivalence, not diagnostic or clinical performance assessed by medical experts. "Ground truth" in this context refers to the measured physical properties and performance characteristics of the device, which are directly measured and compared against established engineering standards or predicate device performance.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical outcomes or diagnoses. The results are typically quantitative measurements compared to predefined criteria or predicate device performance.

5. 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 document is for a hip implant system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This document is for a hip implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

Instrumental Measurements/Benchmarking against Predicates: For the non-clinical testing, the "ground truth" would be the established mechanical properties and performance characteristics of the predicate devices and/or recognized engineering standards for hip implants. The subject device's performance is measured using calibrated instruments and compared directly to these benchmarks.

8. The Sample Size for the Training Set

Not Applicable. This device did not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for an AI/ML algorithm.

Summary of Device and Approval Context:

This 510(k) submission is for "The Progressive Orthopaedic Total Hip System," which consists of additional screw sizes and an apical hole plug for a previously cleared system (K143314). The approval is based on demonstrating substantial equivalence to predicate devices (Progressive Orthopaedic Total Hip System (K143314) and NovoSource NovoHip Total Hip System (K140701)).

The evidence for substantial equivalence primarily relies on non-clinical testing which confirmed that the device has equivalent material, construction, and performance characteristics (mechanical characterization, torsion, driving torque, and pull-out strength) when compared to the predicate devices. No clinical testing was required for this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to create a sense of depth and unity.

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

July 27, 2016

The Progressive Orthopaedic Company, LLC Mr. Thomas Smith Quality/Regulatory Consultant 801 US Highway 1, Suite B North Palm Beach, Florida 33408

Re: K151424 Trade/Device Name: The Progressive Orthopaedic Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: June 24, 2016 Received: June 27, 2016

Dear Mr. Smith:

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 Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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 yours,

Lori A. Wiggins -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)

K151424

Device Name

The Progressive Orthopaedic Total Hip System

Indications for Use (Describe)

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis or traumatic arthritis
· Correction of functional deformity
· Non-union femoral neck fracture
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Type of Use (Select one or both, as applicable)	☒ Production (Part 21 CFR 601 Subpart D)☐ For Test Article (21 CFR 601 Subpart E)	☒ Production (Part 21 CFR 601 Subpart D)	☐ For Test Article (21 CFR 601 Subpart E)
☒ Production (Part 21 CFR 601 Subpart D)
☐ For Test Article (21 CFR 601 Subpart E)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for The Progressive Orthopaedic Company. The logo consists of a blue hexagon with a white caduceus symbol inside. To the right of the hexagon is the company name, with "The" above "PROGRESSIVE" and "Orthopaedic Company" below.

510(k) Summary

Applicant/Sponsor:	The Progressive Orthopaedic Company, LLC.801 US Highway 1, Suite BNorth Palm Beach, FL, 33408(561) 440-4460
Contact Person:	Thomas SmithQuality and Regulatory Consulting801 US Highway 1, Suite BNorth Palm Beach, FL, 33408(203) 641-3936
Proposed Trade Name:	The Progressive Orthopaedic Total Hip System
Common Name:	Hip Joint Prosthesis
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358. Thisfalls under the Orthopedics panel/87 as a Class II device.
Device Product Code:	LPH, LZO
Predicate Devices:	Progressive Orthopaedic Total Hip System (K143314)NovoSource NovoHip Total Hip System (K140701)

Device Description:

The present 510k The Progressive Orthopaedic additional screw sizes and apical hole plug are components to be used with the Progressive Orthopaedic Total Hip System, previously cleared via K143314.

Screw Sizes	6.5mm OD x 15-45mm Length
Material	Ti6Al4V per ASTM 1472
Apical Hole Plug OD	$\u00d8$ 8.52mm OD
Apical Hole Plug Thread	5/16 X 24 UNF 2A
Material	Ti6Al4V

The Progressive Orthopaedic Company 801 US Highway 1, Suite B, North Palm Beach, FL, 33408 Office: (561)440-4460 Fax: (304)777-4790

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Image /page/4/Picture/0 description: The image contains the logo for The Progressive Orthopaedic Company. On the left side of the logo is a blue hexagon with a white caduceus symbol inside. To the right of the hexagon is the company name, with "The" above "PROGRESSIVE" and "Orthopaedic Company" below.

Intended Use:

Hip joint arthroplasty

Indications for Use:

The Progressive Orthopaedic Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and acetabular portions of the hip that are severely disabled and/or very painful as a result of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
Correction of functional deformity
Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Substantial Equivalence

The Progressive Orthopaedic Total Hip System and NovoSource Total Hip System have similar intended use, indications for use and the same manufacturing materials as the predicate device. The range of sizes of the Progressive Ortho Total Hip System is similar to the predicate devices.

Non-Clinical Testing

Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, torsion, driving torque and pull out. In all testing, the subject device shows equivalent properties when compared to predicate products.

Testing has determined that the device is substantially equivalent to the predicate device in material, construction, and performance characteristics.

Clinical Performance Data Summary

No clinical testing was required.

The Progressive Orthopaedic Company 801 US Highway 1, Suite B, North Palm Beach, FL, 33408 Office: (561)440-4460 Fax: (304)777-4790

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.