(23 days)
No
The document describes a mechanical hip implant system and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing and engineering analysis.
Yes
The device is described as a "prosthetic replacement" for the hip joint to treat various conditions, which is a therapeutic intervention.
No
Explanation: The device is a prosthetic hip system intended for replacement of hip joints, not for diagnosing medical conditions.
No
The device description clearly states it is a physical prosthesis fabricated from Ti6Al4V and is compatible with other physical components like femoral heads and stems. The performance studies also focus on mechanical testing of these physical components.
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 patient conditions. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details the materials and components of a hip implant system, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components or processes associated with in vitro diagnostics.
- Performance Studies: The performance studies described are focused on the mechanical and functional properties of the implant (fatigue testing, burst strength, range of motion, etc.), which are relevant to a surgical device, not an IVD.
Therefore, the Klassic HD Hip System is a surgical implant, not an in vitro diagnostic device.
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 (NID): 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, MBL, LPH, LWJ, OQG
Device Description
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). 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:
- Femoral Neck Fatigue testing per ISO 7206-6 of femoral stem with subject +10.5 adapter sleeve and femoral head
- Femoral Stem fatigue per ISO 7206-4 (via Engineering Analysis) of femoral stem with subject +10.5 adapter sleeve and femoral head
- Femoral head burst Strength and Post-fatigue Burst Strength per ISO 7206-10 of ● femoral head and +10.5mm subject adapter sleeve
- Femoral Head Pull-Off testing per ISO 7206-10 of femoral stem with +10.5 subject adapter sleeve and femoral head
- Femoral Head Torque disassembly testing per ISO 7206-13 of femoral stem with ● +10.5 subject adapter sleeve and femoral head
- Impingement per ASTM F2582-14 (via Engineering Analysis) of femoral stem, . +10.5mm subject adapter sleeve, femoral head, acetabular insert and acetabular shell
- . Range of Motion per ISO 21535-07 of femoral stem, +10.5mm subject adapter sleeve, femoral head, acetabular insert and acetabular shell
Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants per AAMI-ST72.
Key Results: Testing and engineering analyses showed that the subject components met the predetermined acceptance criteria identified in the Design Control Activities, demonstrating that the subject component performs as safe and effective compared to the predicate components, and is 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.
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
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 3, 2021
Total Joint Othopedics, Inc. Chris Weaber Director of Research and Development 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K213580
Trade/Device Name: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length 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, MBL, LPH, LWJ, OQG Dated: November 10, 2021 Received: November 10, 2021
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.
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-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.
Limin Sun, Ph.D. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213580
Device Name
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Indications for Use (Describe)
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 (NID): 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) | Residential Use (Per 40 CFR 266 Subpart C) Commercial Use (Per 40 CFR 266 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
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
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: | December 1st, 2021 |
| Device Trade Name: | Adapter Sleeve for BIOLOX® OPTION Femoral Head,
+10.5mm head length |
| Common Name: | Femoral Head Adapter Sleeve |
| 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, MBL, LPH, 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.
4
- . 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. ●
Device Description:
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). 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 Klassic HD® Hip System (K180929, K143407, K100445) 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.
Comparison of Technological Characteristics:
The subject device features the same material (Ti6Al4V per ASTM F136), same intended use as a femoral head adapter, same femoral head and femoral stem taper interface design, similar geometry, same system compatibility, biocompatibility, and same gamma sterilization compared to the predicate Adapter Sleeves (K100445).
Discussion of Non-Clinical Testing/Performance Data:
Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:
- Femoral Neck Fatigue testing per ISO 7206-6 of femoral stem with subject +10.5 adapter sleeve and femoral head
- Femoral Stem fatigue per ISO 7206-4 (via Engineering Analysis) of femoral stem with subject +10.5 adapter sleeve and femoral head
- Femoral head burst Strength and Post-fatigue Burst Strength per ISO 7206-10 of ● femoral head and +10.5mm subject adapter sleeve
- Femoral Head Pull-Off testing per ISO 7206-10 of femoral stem with +10.5 subject adapter sleeve and femoral head
- Femoral Head Torque disassembly testing per ISO 7206-13 of femoral stem with ● +10.5 subject adapter sleeve and femoral head
5
- Impingement per ASTM F2582-14 (via Engineering Analysis) of femoral stem, . +10.5mm subject adapter sleeve, femoral head, acetabular insert and acetabular shell
- . Range of Motion per ISO 21535-07 of femoral stem, +10.5mm subject adapter sleeve, femoral head, acetabular insert and acetabular shell
Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants per AAMI-ST72.
Conclusion:
Testing and engineering analyses showed that the subject components met the predetermined acceptance criteria identified in the Design Control Activities, demonstrating that the subject component performs as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.