(304 days)
No
The summary describes a traditional mechanical hip replacement system with no mention of AI/ML in its intended use, device description, or performance studies.
Yes
The device is an artificial hip replacement system intended to restore joint function by replacing a diseased joint with artificial components.
No
This device is an artificial hip replacement system designed for therapeutic purposes (replacement of 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, acetabular shells, liners, and screws, made from materials like Ti-6AI-4V-ELI, CoCr, and UHMWPE. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the b-ONE® Total Hip System is to replace a diseased or damaged hip joint with artificial components. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an artificial hip replacement system comprised of physical components like femoral stems, heads, acetabular shells, and liners. These are implants used in surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The b-ONE® Total Hip System does not perform this function.
The b-ONE® Total Hip System is a surgical implant used for total hip replacement.
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 (NID), 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 is intended for cementless use only.
b-ONE® Total Hip System components are not intended for use with other total hip systems.
Product codes
LZO, HWC, 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; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.
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.
The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E.
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
Non-Clinical Studies:
- Endurance and Performance
- Burst Test
- Fatigue Test
- Post Fatigue Burst Test
- Axial Pull-off
- Rotational Stability
- Acetabular liner/shell disassembly
- Impingement Test
- Range of Motion Studies
- Accelerated Wear
- Torsional Strength
- Axial Pull-out
- Bacterial Endotoxin Testing
- Shelf Life Studies
- Biocompatibility
- Characterization of Vitamin E
- Polyethylene Liners
- Polyethylene Liner Material
- Characterization of Conventional Polyethylene Liner Material
- Coating Characterization Study
Key Metrics
Not Found
Predicate Device(s)
K052718, K010757, K103479, K001448, K121874, K120370, K091508, K873251
Reference Device(s)
K082844, K161569, K112802, K122158, K111546
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
b-One Ortho Corp. Allison Geick RAC b-ONE Ortho Corp. Regulatory Affairs Manager 3 Wing Drive Suite 259 Cedar Knolls, New Jersey 07927
Re: K173380
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 Dated: August 1. 2018 Received: August 2, 2018
Dear Allison Geick:
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/ofdocs/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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Daniel S. Ramsey -S 2018.08.30 16:41:44 -04'00'
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
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 (NID), 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 is intended for cementless use only.
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."
3
K173380 TRADITIONAL 510(K) SUMMARY
Submitter Information:
| Submitter's Name: | b-One Ortho |
|---|---|
| Address: | 3 Wing Drive |
| Suite 259 | |
| Cedar Knolls, NJ 07927 | |
| Telephone: | 866-276-4538 |
| Contact Person: | Allison Gecik |
| Telephone: | 973-587-8431 |
| Date Prepared: | July 31, 2018 |
| Proprietary Name: | b-ONE® Total Hip System |
| Classification: | Class II |
| Classification Panel: | Orthopedic |
| Common Name: | Total Hip Joint Replacement |
| Product Code(s): | LZO, HWC, MEH |
| Classification | |
| Name(s): | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis (888.3353) | |
| Screw, fixation, bone, smooth or threaded metallic bone fixation | |
| fastener (888.3040) | |
| Legally Marketed Predicate | |
| Devices to Which Substantial | |
| Equivalence is Claimed: | K052718, StrykerV40TM Biolox® delta Ceramic Femoral Heads |
| K010757, Stryker V40™ Femoral Head Components | |
| K103479 Accolade II Hip Stem | |
| K001448 Stryker Trident Acetabular Shells: HA over PPS | |
| K121874 Biomet G7 Acetabular System | |
| K120370 Zimmer Continuum Acetabular System (UHMWPE+VitE) | |
| K091508 Zimmer Continuum Acetabular System (UHMWPE) | |
| K873251Stryker Self-Tapping Acetabular Screw | |
| Legally Marketed Reference | |
| Devices Used to Support | |
| Substantial Equivalence: | K082844 Biolox Ceramic Femoral Heads |
| K161569 Stryker Trident Acetabular Shells | |
| K112802, K122158 Pipeline Total Hip System | |
| K111546, United Orthopedic Corp. U2 Hip Sytem |
4
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.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid 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 is intended for cementless 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; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.
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.
The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E.
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 and the predicate devices share the following characteristics:
- . Materials of construction
- Manufacturing processes ●
- Sizes offered
- Product design for shape and macrostructures
- Coatings (titanium and hydroxyapatite coating options)
- . Sterilization methods
Performance Testing - Bench
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
| • Endurance and Performance | • Accelerated Wear |
|---|---|
| • Burst Test | • Torsional Strength |
| • Fatigue Test | • Axial Pull-out |
| • Post Fatigue Burst Test | • Bacterial Endotoxin Testing |
5
| • Axial Pull-off | • Shelf Life Studies |
|---|---|
| • Rotational Stability | • Biocompatibility |
| • Acetabular liner/shell disassembly | • Characterization of Vitamin E |
| Polyethylene Liners | Polyethylene Liner Material |
| • Impingement Test | • Characterization of Conventional |
| Polyethylene Liner Material | |
| • Range of Motion Studies | • Coating Characterization Study |
Conclusion
The information provided above supports that the b-One® Total Hip System 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 is substantially equivalent to the predicate devices.