(266 days)
No
The provided text describes a mechanical implant (femoral stem and cement restrictor) and its intended use, materials, and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a total hip system, intended for primary or revision total hip replacement, which are medical procedures to treat severely disabled or damaged hip joints. This directly addresses medical conditions and aims to restore function, meeting the definition of a therapeutic device.
No
The device is a total hip replacement system, which is a prosthetic orthopedic implant, not a diagnostic tool. Its intended use is to replace a severely disabled or damaged hip joint.
No
The device description clearly outlines physical components made of titanium alloy, stainless steel, and UHMWPE, which are hardware. The performance studies also focus on mechanical properties and biocompatibility of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The b-ONE® Total Hip System is a medical device intended for surgical implantation to replace a damaged hip joint. It consists of femoral stems and a cement restrictor.
- Intended Use: The intended use clearly states it's for "primary or revision total hip replacement" in patients with specific hip conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is an implantable medical device used in surgery, not a diagnostic tool used with in vitro specimens.
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 and Grit-Blasted stems are intended for cementless use only.
The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.
The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
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, JDI
Device Description
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.
The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.
The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
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 for b-ONE Total Hip System KOSMO Femoral Stem & Cement Restrictor:
• Range of Motion (ISO 21535)
• Endotoxin Testing (USP)
• Cemented Stem Distal Fatigue (ISO 7206-4)
• Cementless Stem Distal Fatigue (ISO 7206-4)
• Cemented Stem Neck Fatigue (ISO 7206-6)
• Cementless Stem Neck Fatigue (ISO 7206-6)
• Material Characterization
• Biocompatibility Assessment (ISO 10993-1)
Key results: The information provided above supports that the b-ONE® Total Hip System components are as safe and effective as the predicate devices with similar intended uses. 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 components are 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.
(K202768)
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.
(K070554; K042992), (K182705), (K030122), (K800894)
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
November 15, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
b-ONE Ortho, Corp. Allison Gecik Director, US Quality & Regulatory 3 Wing Drive Suite 259 Cedar Knolls, New Jersey 07927
Re: K240528
Trade/Device Name: b-ONE® Total 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, MEH, JDI Dated: October 18, 2024 Received: October 18, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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 -S
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
3
Indications for Use
Submission 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 and Grit-Blasted stems are intended for cementless use only.
The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.
The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
b-ONE® 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: | November 15, 2024 |
- Proprietary Name:
b-ONE® Total Hip System
Classification Panel: Orthopedic
Classification: Class II
Classification Regulation/Product Codes:
| Subject Devices | Product Code | Regulation Number | Regulation Name |
|---|---|---|---|
| b-ONE® Total Hip System | LZO | 888.3353 | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. |
| MEH | 888.3353 | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | |
| JDI | 888.3350 | Hip joint metal/polymer semi-constrained cemented prosthesis |
Predicate Device and Reference Devices:
| Predicate and Reference Device Alignment to the b-ONE® Total Hip System Components | |||
|---|---|---|---|
| Subject Devices | Primary Predicate | ||
| Device Per | |||
| Component | Corresponding | ||
| Predicate | |||
| Regulatory | |||
| Information | |||
| (Primary) | Applicable Reference Devices | ||
| b-ONE® Total Hip System | (K202768), The b- | ||
| ONE™ Total Hip | |||
| System KOSMO™ | |||
| Femoral Stems | 888.3353 | ||
| LZO, MEH | (K070554; K042992), DePuy | ||
| Corail Stem; DePuy Corail | |||
| AMT Stem |
5
| | | (K182705) b-ONE Total Hip
System Juveno Femoral Stem
(K030122), DePuy Summit
Basic Press-Fit Hip Prosthesis
(K800894), Depuy Cement
Restrictor Trials &
Instruments |
| -- | -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 and Grit-Blasted stems are intended for cementless use only.
The b-ONE® Total Hip System KOSMO™ stainless steel stems are intended for cemented use only.
The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
b-ONE® Total Hip System components are not intended for use with other total hip systems.
Device Description/Technological Characteristics for b-ONE Total Hip System KOSMO Femoral Stem
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.
The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.
6
Device Description/Technological Characteristics for b-ONE Total Hip System Cement Restrictor
The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
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® Hip System components and the primary predicate device share the following characteristics:
- Materials of construction
- Sizes within the same range
- Similarity in shape ●
- Coatings
- Fixation ●
- Sterilization methods ●
Differences between the subject components and primary predicate device include: introduction of gritblasted stems, additional neck geometries and cement restrictor is being introduced for use with the subject cemented stems.
Performance Testing - Bench
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies for b-ONE Total Hip System KOSMO Femoral Stem & Cement Restrictor
| • Range of Motion (ISO 21535) | • Endotoxin Testing (USP) |
|---|---|
| • Cemented Stem Distal Fatigue (ISO 7206-4) | • Cementless Stem Distal Fatigue (ISO 7206-4) |
| • Cemented Stem Neck Fatigue (ISO 7206-6) | • Cementless Stem Neck Fatigue (ISO 7206-6) |
| • Material Characterization | • Biocompatibility Assessment (ISO 10993-1) |
Conclusion
This subject 510(k) premarket notification is being submitted as a line existing b-ONE® Total Hip System devices. Additional stem options and a cement restrictor are being submitted to add to the previously cleared b-ONE Kosmo Femoral Stem System (K202768).
The information provided above supports that the b-ONE® Total Hip System components are as safe and effective as the predicate devices with similar intended uses. 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 components are substantially equivalent to the predicate devices.