Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

K182705 · B-One Ortho, Corp. · LZO · Feb 14, 2019 · Orthopedic

Device Facts

• Record ID: K182705
• Device Name: Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
• Applicant: B-One Ortho, Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Feb 14, 2019
• 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 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.

Device Story

Artificial hip replacement system consisting of femoral stems, femoral heads, acetabular shells, acetabular liners, and optional acetabular screws. Used by orthopedic surgeons in clinical settings to replace diseased hip joints, restoring function. Components are implanted cementlessly. System is closed; components are not compatible with other manufacturers' systems. Device provides mechanical structural support to replace damaged bone/joint tissue.

Clinical Evidence

Bench testing only. Studies included fatigue testing, endurance and performance testing, impingement testing, accelerated wear testing, acetabular liner/shell disassembly testing, biocompatibility, shelf life studies, bacterial endotoxin testing, and coating characterization.

Technological Characteristics

Materials: Ti-6Al-4V-ELI. Coatings: CPTi Plasma Porous Spray with or without hydroxyapatite (HA). Components: Femoral stems, femoral heads, acetabular shells (no-hole/multi-hole), acetabular liners, 6.5mm acetabular screws. Form factor: Modular hip prosthesis. Sterilization: Supplied sterile, single-use.

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 (including rheumatoid arthritis and congenital dysplasia), nonunion, acute traumatic femoral head/neck fracture, failed endoprosthesis, femoral osteotomy, Girdlestone resection, or fracture-dislocation.

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

• b-ONE® Ortho Total Hip System (K173380)

Submission Summary (Full Text)

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February 14, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

b-ONE Ortho Corp. Allison Gecik Regulatory Affairs Manager 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927

Re: K182705

Trade/Device Name: Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups 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: January 14, 2019 Received: January 15, 2019

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2019.02.14 14:15:47 -05'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K182705

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 is intended for cementless use only.

b-ONE® Total Hip System components are not intended for use with other total hip systems. Type of

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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## K# 182705 TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92

### Submitter Information:

| Submitter's Name: | b-ONE Ortho, Corp. |
|----------------------------|------------------------------------------------------------------------------------------------------------|
| 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: | January 7, 2019 |
| Proprietary Name: | b-ONETM Total Hip System |
| Classification: | Class II |
| Classification Panel: | Orthopedic |
| Common Name: | Total Hip Joint Replacement |
| Product Code(s): | LZO, MEH |
| Classification<br>Name(s): | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (888.3353) |

#### Legally Marketed Predicate K173380, b-ONE® Ortho Total Hip System Devices to Which Substantial Equivalence is Claimed:

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 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-ONETM Total Hip System is intended for cementless use only.

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### K182705

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 and Acetabular Shells are made from Ti-6A1-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. The subject devices are identical to the predicate devices, with the exception that there has been an additional supplier qualified for coatings.

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 | • Fatigue Test |
|-------------------------------------------------------------|----------------------------------|
| • Impingement Test | • Accelerated Wear |
| • Acetabular Liner/Shell Disassembly<br>Polyethylene Liners | • Bacterial Endotoxin Testing |
| • Biocompatibility | • Shelf Life Studies |
| • 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. The b-ONE™ Total Hip System is substantially equivalent to the predicate devices.