(192 days)
No
The summary describes a mechanical hip replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "an artificial hip replacement system" with the therapeutic effect of "replacement of the diseased joint with artificial components to restore joint function."
No.
The device is an artificial hip replacement system intended for therapeutic purposes (replacing a diseased joint), not for diagnosing conditions.
No
The device description clearly states it is an artificial hip replacement system comprised of physical components like femoral stems, heads, and acetabular shells, which are hardware.
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 surgical implant for replacing a diseased or damaged hip joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as an artificial hip replacement system comprised of physical components (stems, heads, shells, liners, screws) designed to restore joint function.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used within the human body.
N/A
Intended Use / Indications for Use
The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:
Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.
The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.
b-ONE™ Total Hip System components are not intended for use with other total hip systems.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The b-ONE Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; optional acetabular bone screws. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.
This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only.
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.
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
skeletally mature patients
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)
Performance Testing - Bench
Non-Clinical Studies:
• Endurance and Performance
• Impingement Testing
• Biocompatibility
• Range of Motion Study
• Bacterial Endotoxin Testing
• Shelf Life Studies
Key results: The information provided above supports that the b-ONE™ Total Hip System KOSMO™ Femoral Stem is as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness. The b-ONE™ Total Hip System KOSMO™ Femoral Stem is substantially equivalent to the predicate devices.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two main elements: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue.
b-One Ortho Corp. Allison Gecik Regulatory Affairs Associate Director 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927
Re: K202768
Trade/Device Name: KOSMO Femoral Stem 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 25, 2021 Received: February 26, 2021
Dear Allison Gecik:
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 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
510(k) Number (if known)
Device Name b-ONE™ Total Hip System
Indications for Use (Describe)
The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:
Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.
The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.
b-ONETM Total Hip System components are not intended for use with other total hip systems.
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) |
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3
TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | b-ONE ORTHO, Corp. | |
|---|---|---|
| Address: | 3 Wing Drive | |
| Suite 259 | ||
| Cedar Knolls, NJ 07927 | ||
| Telephone: | 866-276-4538 | |
| Contact Person: | Allison Gecik | |
| Telephone: | 973-587-8431 | |
| Date Prepared: | September 18, 2020 | |
| Proprietary Name: | b-ONE TM Total Hip System | |
| Classification: | Class II | |
| Classification Panel: | Orthopedic | |
| Common Name: | Total Hip Joint Replacement | |
| Product Code(s): | LZO, MEH | |
| Classification Name(s): | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | (888.3353) |
| Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: | K070554, K042992 DePuy Corail Stem; DePuy Corail AMT Stem | |
| Legally Marketed Reference Devices Used to Support Substantial Equivalence: | K192189, K182048 Zimmer Biomet Avenir Complete Hip Stem | |
Intended Use: The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:
Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
4
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.
The b-ONE Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONE™ Total Hip System KOSMO™ stainless steel stems are intended for cemented use only.
b-ONE™ Total Hip System components are not intended for use with other total hip systems.
Device Description/Technological Characteristics:
The b-ONE Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; optional acetabular bone screws. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.
This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only.
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.
Comparison of Technological Characteristics (compared to Predicate(s))
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The b-ONE Total Hip System KOSMO™ Femoral Stem and the predicate devices share the following characteristics:
- Materials of construction
- Manufacturing processes
- Sizes offered
- Product design for shape
- Coatings ●
- Sterilization methods
Performance Testing - Bench
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
| • Endurance and Performance | • Range of Motion Study |
|---|---|
| • Impingement Testing | • Bacterial Endotoxin Testing |
| • Biocompatibility | • Shelf Life Studies |
5
Conclusion
The information provided above supports that the b-ONE™ Total Hip System KOSMO™ Femoral Stem is as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness. The b-ONE™ Total Hip System KOSMO™ Femoral Stem is substantially equivalent to the predicate devices.