(217 days)
Not Found
No
The summary describes a mechanical hip implant system and the testing performed is focused on material properties and mechanical performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a prosthetic replacement for the hip joint, intended to treat various painful and degenerative joint conditions, which falls under the definition of a therapeutic device.
No
Explanation: The device is a prosthetic hip replacement system, indicated for surgical implantation to treat various hip joint conditions. Its purpose is to restore hip joint biomechanics, not to diagnose a condition.
No
The device description clearly states it is a hip system employing prostheses made from materials like Ti6Al4V and UHMWPE, and includes physical components like acetabular shells and inserts. This indicates a hardware-based medical device, not software-only.
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 a prosthetic replacement for the hip joint in various conditions. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the materials and components of a hip implant (acetabular shells and inserts). This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Klassic HD® Hip System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
- Revision of a previously failed hip arthroplasty. ●
- Patients who require a total hip replacement. ●
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, MBL, OQG
Device Description
The Klassic HD Hip System employs prostheses designed to help surgeons restore hip joint biomechanics. The purpose of this 510(k) is to add the Platform Acetabular System consisting of the Platform Acetabular Shell with Ti-Coat and Platform Acetabular Inserts with E-Link (Neutral and Hooded) to the Klassic HD Hip System. The Platform Acetabular Shells are fabricated from Ti6Al4V per ASTM F136 and the Platform Acetabular Inserts with E-Link are made from Vitamin E. UHMWPE material. The subject acetabular components are available in various sizes ranging in outer diameters of 44mm to 64mm to match patient anatomy and are compatible with 28mm, 32mm, and 36mm heads. The subject components are provided sterile, for single use, by prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:
- Material wear (via engineering analysis) of acetabular shells and liners ●
- Range of motion (via engineering analysis)
- Push out testing per ASTM F1820-13 ●
- Lever out testing per ASTM F1820-13 ●
- Axial Torque Disassembly Testing per ASTM F1820-13
- Impingement Testing per ASTM F2582-20
- Acetabular Shell Fatigue Testing per ASTM F3090-20
- Deformation Testing per ISO 7206-12 .
Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K100445, K141972, K173104, K180929
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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September 23, 2022
Total Joint Orthopedics, Inc. % Holly Rhodes Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K220483
Trade/Device Name: Platform® Acetabular 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, LPH, MBL, OQG Dated: July 25, 2022 Received: July 25, 2022
Dear Holly 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
510(k) Number (if known)
K220483
Device Name Platform® Acetabular System
Indications for Use (Describe)
ankylosis, protrusio acetabuli and painful hip dysplasia.
• Revision of a previously failed hip arthroplasty. · Patients who require a total hip replacement.
· Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over The Counter Use (21 CFR 801 Subpart C) |
The Klassic HD Hip System is intended for prosthetic replacement in treatment of the following:
· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis,
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510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City, UT 84106
Phone: 801.486.6070
Fax: 801.486.6117 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Director of Research and Development |
| Prepared By: | MCRA, LLC
803 7th Street NW
Washington, DC 20001
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | September 21, 2022 |
| Device Trade Name: | Platform® Acetabular System |
| Common Name: | Acetabular Shell, Acetabular Inserts |
| Classifications: | 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis
21 CFR 888.3358 - Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis
Class II |
| Product Codes: | LZO, LPH, MBL, OOG |
Indications for Use:
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
- Revision of a previously failed hip arthroplasty. ●
- Patients who require a total hip replacement. ●
4
Device Description:
The Klassic HD Hip System employs prostheses designed to help surgeons restore hip joint biomechanics. The purpose of this 510(k) is to add the Platform Acetabular System consisting of the Platform Acetabular Shell with Ti-Coat and Platform Acetabular Inserts with E-Link (Neutral and Hooded) to the Klassic HD Hip System. The Platform Acetabular Shells are fabricated from Ti6Al4V per ASTM F136 and the Platform Acetabular Inserts with E-Link are made from Vitamin E. UHMWPE material. The subject acetabular components are available in various sizes ranging in outer diameters of 44mm to 64mm to match patient anatomy and are compatible with 28mm, 32mm, and 36mm heads. The subject components are provided sterile, for single use, by prescription only.
Predicate Devices:
The modified Klassic HD Hip System is substantially equivalent to the predicate Klassic HD® Hip System (Primary predicate: K100445; Additional predicates: K141972, K173104, K180929) with respect to indications, design, material and function. The information summarized in this 510(k) demonstrates that the subject device is substantially equivalent to the identified predicate devices.
Comparison of Technological Characteristics:
The subject devices feature the same material (Ti6A14V per ASTM F136 and Vitamin E UHMWPE), same use as acetabular shells and liners, same articular interface design, same compatibility, and same sterilization as predicate shells and liners (K100445).
Discussion of Non-Clinical Testing/ Performance Data:
The subject device underwent push out testing, lever out testing, axial torque disassembly testing, impingement testing, acetabular shell fatigue testing, and deformation testing. In addition, engineering analysis was performed to evaluate material wear and range of motion for the subject devices. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.
Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:
- Material wear (via engineering analysis) of acetabular shells and liners ●
- Range of motion (via engineering analysis)
- Push out testing per ASTM F1820-13 ●
- Lever out testing per ASTM F1820-13 ●
- Axial Torque Disassembly Testing per ASTM F1820-13
- Impingement Testing per ASTM F2582-20
- Acetabular Shell Fatigue Testing per ASTM F3090-20
- Deformation Testing per ISO 7206-12 .
Conclusion
Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate.