The Progressive Orthopaedic Total Hip System implant components are in cementless reconstruction of the articulating surface of femoral and/or 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 submission is for a non-cemented primary hip prosthesis that consists of a 4part total hip replacement system including femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.

The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.

The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "The Progressive Orthopaedic Total Hip System". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance as would typically be seen for AI/Software as a Medical Device (SaMD).

Therefore, the information requested for AI/SaMD performance studies is largely not applicable to this submission. This document details non-clinical laboratory testing to prove mechanical and material equivalence.

However, I can extract the relevant information from the document as it pertains to the type of acceptance criteria and the testing done to meet regulatory requirements for this specific device.

Acceptance Criteria and Device Performance (Not applicable in the typical AI/SaMD sense as this is a mechanical prosthesis):

The document states that "All devices met the required performance specifications for testing and are considered equivalent to the predicate devices." The acceptance criteria are implicitly tied to the performance of the predicate device and established standards for hip prostheses, but specific numerical thresholds are not detailed in this summary.

Here's a table based on the non-clinical tests performed:

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Fatigue Performance Test for Progressive Orthopaedic Stem	Meet established standards for hip stem fatigue and predicate	Met required performance specifications
Fatigue Performance Test for the Neck Portion of the Stem	Meet established standards for neck fatigue and predicate	Met required performance specifications
Disassembly Force Test for Neck Taper/Femoral Head Interface	Meet established standards for interface integrity and predicate	Met required performance specifications
Range of Motion Test for Total Hip System	Achieve functional range of motion and predicate	Met required performance specifications
Burst Strength Test for Ceramic Femoral Heads (Static)	Withstand static compression forces and predicate	Met required performance specifications
Cyclic Fatigue Test for Ceramic Femoral Heads (Cyclic)	Withstand cyclic compression forces and predicate	Met required performance specifications
Post-Cyclic Fatigue Burst Test for Ceramic Femoral Heads (Static)	Withstand static compression after cyclic loading and predicate	Met required performance specifications
Pull-Off Test for Ceramic Femoral Heads	Demonstrate adequate pull-off strength and predicate	Met required performance specifications
Rotational Stability Test for Ceramic Femoral Heads	Demonstrate adequate rotational stability and predicate	Met required performance specifications
Torsional Properties Test for Bone Screws	Meet established standards for screw torsion and predicate	Met required performance specifications
Driving Torque Test for Bone Screws	Meet established standards for screw driving torque and predicate	Met required performance specifications
Axial Pull-Out Strength Test for Bone Screws	Meet established standards for screw pull-out and predicate	Met required performance specifications
Lever-Out Test for Acetabular Shell/Liner Assembly	Demonstrate resistance to lever-out forces and predicate	Met required performance specifications
Torque-Out Test for Acetabular Shell/Liner Assembly	Demonstrate resistance to torque-out and predicate	Met required performance specifications
Push-In Test for Acetabular Shell/Liner Assembly	Demonstrate appropriate push-in forces and predicate	Met required performance specifications
Push-Out Test for Acetabular Shell/Liner Assembly	Demonstrate appropriate push-out forces and predicate	Met required performance specifications

Additional Information (Specific to AI/SaMD, but N/A for this device):

Sample size used for the test set and the data provenance: Not applicable. This device is a mechanical prosthesis, not a software device relying on a test set of data. The "samples" would be the physical devices or components tested in the lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurements and engineering standards, not expert consensus on data.
Adjudication method for the test set: Not applicable.
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 not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is based on established engineering standards (e.g., ISO standards for implant testing), material specifications, and performance data from the legally marketed predicate device (NovoSource NovoHip Total Hip System).
The sample size for the training set: Not applicable. This device is not developed using machine learning that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The Progressive Orthopaedic Total Hip System underwent a series of non-clinical, in-vitro laboratory tests, including fatigue, strength, stability, and disassembly tests for its various components (stem, femoral head, acetabular shell/liner, bone screws). The acceptance criteria were implicitly defined by relevant engineering standards for orthopedic implants and by demonstrating equivalence to the predicate device, NovoSource NovoHip Total Hip System (K132158). The document states that all devices met the required performance specifications for testing, leading to the conclusion that the device is substantially equivalent to the predicate. 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 features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized caduceus, with a double helix intertwined with a staff, representing health and medicine.

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

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

February 27, 2015

Re: K143314 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: November 25, 2014 Received: December 02, 2014

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

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Page 2 - Mr. Thomas Smith

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/Resourcesfor You/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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143314

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)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Consultant801 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 and Hipjoint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis per 21 CFR 888.3390. This falls underthe Orthopedics panel/87 as a Class II device.
Device Product Code:	LPH, LZO
Predicate Devices:	NovoSource NovoHip Total Hip System (K132158)

Device Description:

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Image /page/4/Picture/0 description: The image shows the text 'K143314' in a simple, sans-serif font. The text is black and appears to be on a white background. The numbers and letters are evenly spaced and clearly legible.

Image /page/4/Picture/2 description: The image is a logo for The Progressive Orthopaedic Company. The logo features a blue hexagon with a white caduceus symbol inside. To the right of the hexagon is the company name, "The Progressive Orthopaedic Company", with "The" in a smaller font above "Progressive" and "Orthopaedic Company" in a smaller font below "Progressive".

The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.

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/or 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.

Summary of Studies

Non-Clinical Testing

The Progressive Orthopaedic Total Hip System underwent the following testing:

Fatigue Performance Test for Progressive Orthopaedic Stem
Fatigue Performance Test for the Neck Portion of the Progressive Orthopaedic Stem
Disassembly Force Test for the Progressive Orthopaedic Neck Taper/Femoral Head Interface
Range of Motion Test for the Progressive Orthopaedic Total Hip System
. Burst Strength Test for Progressive Orthopaedic Ceramic Femoral Heads (Static Compression)
. Cyclic Fatigue Test for Progressive Orthopaedic Ceramic Femoral Heads (Cyclic Compression)

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Image /page/5/Picture/1 description: The image shows the logo for The Progressive Orthopedic 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 "Orthopedic Company" below. The text is in black.

Post-Cyclic Fatigue Burst Test for Progressive Orthopaedic Ceramic Femoral Heads ● (Static Compression)
. Pull-Off Test for Progressive Orthopaedic Ceramic Femoral Heads
Rotational Stability Test for Progressive Orthopaedic Ceramic Femoral Heads ●
Torsional Properties Test for Progressive Orthopaedic Bone Screws ●
Driving Torque Test for Progressive Orthopaedic Bone Screws
Axial Pull-Out Strength Test for Progressive Orthopaedic Bone Screws
. Lever-Out Test for Progressive Orthopaedic Acetabular Shell/Liner Assembly
Torque-Out Test for Progressive Orthopaedic Acetabular Shell/Liner Assembly
. Push-In Test for Progressive Orthopaedic Acetabular Shell/Liner Assembly
Push-Out Test for Progressive Orthopaedic Acetabular Shell/Liner Assembly

All devices met the required performance specifications for testing and are considered equivalent to the predicate devices.

Clinical Testing

No clinical testing was required.

Conclusion

Based on testing results and the comparisons provided, the Progressive Orthopaedic Total Hip System is considered substantially equivalent to the NovoSource NovoHip Total Hip System in material, construction and performance characteristics.

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.