b-ONE® Total Hip System

K173380 · B-One Ortho, Corp. · LZO · Aug 30, 2018 · Orthopedic

Device Facts

• Record ID: K173380
• Device Name: b-ONE® Total Hip System
• Applicant: B-One Ortho, Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

b-ONE® Total Hip System is an artificial hip replacement system; consists of femoral stems, femoral heads, acetabular shells, acetabular liners, and optional 6.5mm acetabular screws. Used by orthopedic surgeons in clinical settings to replace diseased hip joints; restores joint function. Components are non-interchangeable with other systems; intended for cementless fixation. System provides mechanical replacement of hip joint anatomy; benefits patient through restoration of mobility and reduction of pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Performance data includes endurance, burst, fatigue, torsional strength, axial pull-out/pull-off, rotational stability, impingement, range of motion, accelerated wear, bacterial endotoxin, shelf life, biocompatibility, and material characterization (Vitamin E, coating, polyethylene).

Technological Characteristics

Materials: Ti-6Al-4V-ELI, CoCr, Biolox delta ceramic, conventional UHMWPE, and Vitamin E-stabilized UHMWPE. Coatings: CPTi Plasma Porous Spray with/without HA. Components: Tapered wedge stems, acetabular shells (no-hole/multi-hole), liners, 6.5mm screws. Single-use, sterile. Cementless fixation.

Indications for Use

Indicated for skeletally mature patients requiring primary or revision total hip replacement due to osteoarthritis, traumatic arthritis, avascular necrosis, NIDJD, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant, inflammatory degenerative joint disease (e.g., rheumatoid arthritis), congenital dysplasia, nonunion, acute traumatic fracture of femoral head/neck, failed endoprosthesis, femoral osteotomy, Girdlestone resection, or fracture-dislocation. Intended for cementless use only.

Regulatory Classification

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.

Predicate Devices

• StrykerV40TM Biolox® delta Ceramic Femoral Heads (K052718)
• Stryker V40™ Femoral Head Components (K010757)
• Accolade II Hip Stem (K103479)
• Stryker Trident Acetabular Shells: HA over PPS (K001448)
• Biomet G7 Acetabular System (K121874)
• Zimmer Continuum Acetabular System (UHMWPE+VitE) (K120370)
• Zimmer Continuum Acetabular System (UHMWPE) (K091508)
• Stryker Self-Tapping Acetabular Screw (K873251)

Reference Devices

• Biolox Ceramic Femoral Heads (K082844)
• Stryker Trident Acetabular Shells (K161569)
• Pipeline Total Hip System (K112802, K122158)
• United Orthopedic Corp. U2 Hip Sytem (K111546)

Submission Summary (Full Text)

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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

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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 [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K173380

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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K173380 TRADITIONAL 510(K) SUMMARY

## Submitter Information:

| Submitter's Name: | b-One Ortho |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3 Wing Drive<br>Suite 259<br>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<br>Name(s): | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (888.3353)<br>Screw, fixation, bone, smooth or threaded metallic bone fixation<br>fastener (888.3040) |
| Legally Marketed Predicate<br>Devices to Which Substantial<br>Equivalence is Claimed: | K052718, StrykerV40TM Biolox® delta Ceramic Femoral Heads<br>K010757, Stryker V40™ Femoral Head Components<br>K103479 Accolade II Hip Stem<br>K001448 Stryker Trident Acetabular Shells: HA over PPS<br>K121874 Biomet G7 Acetabular System<br>K120370 Zimmer Continuum Acetabular System (UHMWPE+VitE)<br>K091508 Zimmer Continuum Acetabular System (UHMWPE)<br>K873251Stryker Self-Tapping Acetabular Screw |
| Legally Marketed Reference<br>Devices Used to Support<br>Substantial Equivalence: | K082844 Biolox Ceramic Femoral Heads<br>K161569 Stryker Trident Acetabular Shells<br>K112802, K122158 Pipeline Total Hip System<br>K111546, United Orthopedic Corp. U2 Hip Sytem |

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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 |

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| • 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<br>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.