(94 days)
Not Found
No
The 510(k) summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a femoral component of a total hip replacement or partial hip replacement, intended to treat conditions like osteoarthritis and hip fractures. By replacing part of the hip joint, it directly treats and alleviates the symptoms of these conditions, which is the definition of a therapeutic device.
No
The provided text describes the Paragon™ Hip System, which is a femoral component for hip replacement surgery. Its intended use is to replace a damaged or diseased hip component, not to diagnose a condition.
No
The device description clearly states the Paragon™ Hip System is a physical femoral hip stem manufactured from titanium alloy and Hydroxyapatite, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Paragon™ Hip System is a femoral component for total or partial hip replacement. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the physical characteristics and materials of a hip stem, which is a physical implant.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
-
- Degenerative osteoarthritis of the hip.
-
- Inflammatory arthritis of the hip.
-
- Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
-
- Displaced intracapsular femoral neck fractures where ts a high risk of non-union or avascular necrosis and bone collapse.
-
- Avascular Necrosis of the femoral head.
-
- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.
Product codes
LZO, MEH
Device Description
The Paragon™ Hip System is to be used in conjunction with a compatible femoral head and acetabular component as part of a total hip arthroplasty, or as the femoral stem in a hemiarthroplasty.
The body of the Paragon™ Hip System tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a bi-planar wedge geometry that is conducive to axial and rotational stability.
The Paragon™ Hip System is manufactured from titanium alloy (Ti6A14V ELI per ASTM F136) and Hydroxyapatite (HA) (ISO 13779-1 for the HA powder and ISO 13779-2 for the coating).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The preclinical tests performed on the Paragon™ Hip System include Range of Motion, Stem Fatigue Testing, Neck Fatigue Testing, Burst Strength Testing when coupled with ceramic femoral heads, and characterization of the stem's HA coating. The results support the substantial equivalence of the Paragon™ Hip System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K123782 Page 1 of 2
510(k) Summary
MAR 1 4 2013
| Device Trade Name: | Paragon™ Hip System |
|---|---|
| Manufacturer: | Global Manufacturing Technology |
| Unit 7, 12 Boden Road | |
| Seven Hills, NSW 2147 AUSTRALIA | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Office: 202.552.5800 | |
| Fax: 202.552.5798 | |
| Date Prepared: | February 5, 2013 |
| Classifications: | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi- |
| constrained cemented or nonporous uncemented prosthesis. | |
| Class: | II |
| Product Codes: | LZO, MEH |
Indications for Use:
The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
-
- Degenerative osteoarthritis of the hip.
-
- Inflammatory arthritis of the hip.
-
- Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
-
- Displaced intracapsular femoral neck fractures where ts a high risk of non-union or avascular necrosis and bone collapse.
-
- Avascular Necrosis of the femoral head.
-
- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.
Device Description:
The Paragon™ Hip System is to be used in conjunction with a compatible femoral head and acetabular component as part of a total hip arthroplasty, or as the femoral stem in a hemiarthroplasty.
1
The body of the Paragon™ Hip System tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a bi-planar wedge geometry that is conducive to axial and rotational stability.
The Paragon™ Hip System is manufactured from titanium alloy (Ti6A14V ELI per ASTM F136) and Hydroxyapatite (HA) (ISO 13779-1 for the HA powder and ISO 13779-2 for the coating).
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the Paragon™ Hip System to the following predicate devices: DePuy Orthopaedics Corail Hip (K042992), Smith & Nephew's Anthology Hip (K052792), and Consensus CS2TM Hip System (K122512).
Substantial Equivalence:
The components of the Paragon™ Hip System are substantially equivalent to the identified predicates with respect to indications for use, geometry, available sizes, materials, performance and function.
Preclinical Testing:
The preclinical tests performed on the Paragon™ Hip System include Range of Motion, Stem Fatigue Testing, Neck Fatigue Testing, Burst Strength Testing when coupled with ceramic femoral heads, and characterization of the stem's HA coating. The results support the substantial equivalence of the Paragon™ Hip System.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three horizontal lines above it, representing the department's mission to promote health and well-being. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle above the eagle, and the word "DEPART" is below the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 14, 2013
Global Manufacturing Technology % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Hollace S. Rhodes Director, Orthopedic Regulatory Affairs 1331 H Street, Northwest, 12th Floor Washington, DC 20005
Re: K123782
Trade/Device Name: Paragon™ Hip System 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: LZO, MEH Dated: February 7, 2013
Received: February 11, 2013
Dear Ms. Rhodes:
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. Ilsting 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
3
Page 2 -- Ms. Hollace S. Rhodes
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 (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
-rin - DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K123782
Device Name: Paragon™ Hip System
The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
-
- Degenerative osteoarthritis of the hip.
-
- Inflammatory arthritis of the hip.
- Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral 3. neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
-
- Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.
-
- Avascular Necrosis of the femoral head.
-
- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.
Prescription Use V (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use no (29 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethi i: Frank -S
Division of Orthopedic Devices