(30 days)
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No
The summary describes a hip replacement system with mechanical components and provides performance data based on engineering tests. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a prosthetic replacement intended for the treatment of various joint diseases and conditions, falling under the definition of a therapeutic device.
No
The device is a prosthetic replacement for the hip joint, used in treatment or revision of various hip conditions. It does not perform diagnostic functions but rather provides a mechanical solution for existing medical conditions.
No
The device description clearly states it is a "Hip System" and describes physical components like "Acetabular Cups," "Acetabular Inserts," and "Ceramic Femoral Heads." The performance studies also detail testing of physical properties like "burst strength," "fatigue testing," and "wear testing," which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a prosthetic replacement for the hip joint to treat various conditions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device description details components of a hip replacement system (Acetabular Cups, Inserts, Femoral Heads). These are physical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on the mechanical and physical properties of the implant (burst strength, fatigue, wear, etc.), which are relevant to a surgical device, not an IVD.
In summary, the Klassic HD® Hip System is a surgical implant used for hip replacement, not a device used to perform diagnostic tests in vitro.
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 (NIDJ): 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, OOG, MBL, LWJ
Device Description
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.
Mentions image processing
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis and testing included burst strength testing, fatigue testing, postfatigue burst strength testing and pull off testing of ceramic femoral heads per ISO 7206-10. Analysis and testing also included Push out, lever out, axial torque disassembly per ASTM F1820, Range of Motion per ISO 21535, impingement testing per ASTM F2852 and wear testing per ISO 14242. and all results met the pre-determined acceptance criteria identified in the Design Control Activities. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the pre-determined acceptance criteria for the verification activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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, K161073, K143407, K173104
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
Total Joint Orthopedics, Inc. Mr. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
May 9, 2018
Re: K180929
Trade/Device Name: Klassic HD® 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, LPH, OOG, MBL, LWJ Dated: April 9, 2018 Received: April 9, 2018
Dear Mr. Chris Weaber:
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 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 (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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Indications for Use
510(k) Number (if known) K180929
Device Name Klassic HD® Hip System
| Indications for Use (Describe) |
|---|
| The Klassic HD Hip System is intended for... |
- 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 (NIDJ): 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.
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)
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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
Product Development, Regulatory Manager |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | May 08, 2018 |
| Device Trade Name: | Klassic HD® Hip System |
| Common Name: | Acetabular Shell, Acetabular Insert, Ceramic Femoral Head |
| 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
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic
cemented or uncemented prosthesis.
Class II |
| Product Codes: | LZO, LPH, OQG, MBL, LWJ |
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. ●
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- 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.
Device Description:
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.
Predicate Devices:
The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System Acetabular Cups with Ti-Coat (K100445), Klassic HD® Acetabular Inserts with E-Link® Poly (K141972), Klassic HD® Acetabular Inserts with XLPE (K161073), Klassic HD® Ceramic Femoral Heads (K143407) and the Klassic HD® Hooded and Low Profile Acetabular Inserts with E-Link® Poly (K173104) with respect to indications, design, materials and function.
Substantial Equivalence:
Engineering analysis and testing included burst strength testing, fatigue testing, postfatigue burst strength testing and pull off testing of ceramic femoral heads per ISO 7206-10. Analysis and testing also included Push out, lever out, axial torque disassembly per ASTM F1820, Range of Motion per ISO 21535, impingement testing per ASTM F2852 and wear testing per ISO 14242. and all results met the pre-determined acceptance criteria identified in the Design Control Activities. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the pre-determined acceptance criteria for the verification activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.