(426 days)
No
The summary describes mechanical components (screws and a plug) for a hip replacement system and focuses on material properties and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is an implantable component of a total hip system used for cementless reconstruction, addressing severe hip disabilities and pain caused by various conditions, which are therapeutic indications.
No
The device described is an implant used for hip replacement surgery, not a tool for diagnosis.
No
The device description clearly states that the device consists of physical components (screws and an apical hole plug) made of Ti6Al4V, which are hardware implants for hip reconstruction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for surgical reconstruction of the hip joint. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as implant components (screws and a plug) made of titanium, designed to be used with a total hip system. These are physical components for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing (torsion, driving torque, pull out) to demonstrate the device's structural integrity and equivalence to predicate devices. This is typical for implantable devices, not IVDs.
In summary, the device is a surgical implant for hip replacement, which falls under the category of medical devices used for treatment and structural support, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
LPH, LZO
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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)
Device Name
The Progressive Orthopaedic Total Hip System
Indications for Use (Describe)
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.
| 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 B
North Palm Beach, FL, 33408
(561) 440-4460 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Smith
Quality and Regulatory Consulting
801 US Highway 1, Suite B
North 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. This
falls 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