(96 days)
Not Found
No
The 510(k) summary describes a hip replacement system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical properties and wear, not algorithmic performance.
Yes
The device is a prosthetic replacement for the hip joint, used in the treatment of various joint diseases and failed surgeries to restore hip joint function, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a prosthetic hip replacement system, used for treatment (surgical replacement) of diseased or damaged hip joints, not for diagnosing conditions.
No
The device description clearly states it is a "Hip System" and describes physical components (prostheses, femoral heads) and physical testing (burst strength, fatigue, pull-off, torque disassembly), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a prosthetic replacement for treating various hip joint conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the components of a hip replacement system, specifically focusing on femoral heads. This aligns with a surgical implant.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Performance Studies: The performance studies described (burst strength, fatigue, pull-off, torque, wear) are typical for evaluating the mechanical properties and durability of a surgical implant, not the analytical or clinical performance of a diagnostic test.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used to treat existing conditions by replacing a damaged joint.
N/A
Intended Use / Indications for Use
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, 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, LWJ, OQG
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 BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.
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)
The subject device underwent burst strength testing, burst fatigue testing, post-fatigue burst strength testing, pull-off testing, and torque disassembly testing. In addition, engineering analyses were performed to evaluate the impingement, range of motion and wear of BIOLOX CONTOURA® ceramic femoral heads. Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.
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.
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
August 28, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K191399
Trade/Device Name: BIOLOX CONTOURA Ceramic Femoral Head 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, LWJ, OQG Dated: July 29, 2019 Received: July 29, 2019
Dear 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. 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.
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
1
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-reportingcombination-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 medical devices and radiation-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,
FOR Vesa Vuniqi Acting 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191399
Device Name
BIOLOX CONTOURA® Ceramic Femoral Head
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
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, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City, UT 84106
Phone: 801.486.6070 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Product Development, Regulatory Manager |
| Prepared By: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | May 23, 2019 |
| Device Trade Name: | BIOLOX CONTOURA® Ceramic Femoral Head |
| Common Name: | 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
Class II |
| Product Codes: | LZO, LPH, MBL, LWJ, OQG |
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 intra-operatively. The purpose of this Special 510(k) is to add BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.
Predicate Devices:
The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System (K100445 & K180929), and Klassic HD® Ceramic Femoral Heads (K143407) with respect to indications, design, materials and function. The information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the predetermined acceptance criteria for the verification activities.
Substantial Equivalence:
The subject device underwent burst strength testing, burst fatigue testing, post-fatigue burst strength testing, pull-off testing, and torque disassembly testing. In addition, engineering analyses were performed to evaluate the impingement, range of motion and wear of BIOLOX CONTOURA® ceramic femoral heads. Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities. Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants.