REVIVAL(TM) Modular Revision Hip Stem

K152903 · Corin USA · LZO · Apr 29, 2016 · Orthopedic

Device Facts

• Record ID: K152903
• Device Name: REVIVAL(TM) Modular Revision Hip Stem
• Applicant: Corin USA
• Product Code: LZO · Orthopedic
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REVIVAL™ Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented prosthesis. The indications for the REVIVAL™ Modular Revision Hip Stem include: - Non-inflammatory degenerative joint disease including primary and secondary . osteoarthritis - Rheumatoid arthritis - Correction of functional deformity ● - Treatment of non-union and femoral neck fractures - Treatment of traumatic dislocations of the hip ● - Failures of osteotomy ● - Treatment of arthrodesis The REVIVAL™ Modular Revision Hip Stem is indicated for cementless, single use only.

Device Story

Modular revision hip stem; titanium alloy (Ti6 Al 4V ELI); consists of proximal component, distal component, and locking screw. Proximal component available in multiple lengths/angles; distal component conical with longitudinal fins. Components assembled via 2° 51' Morse taper and secured with locking screw; allows adjustment of anteversion. Surface finish abraded with corundum for cementless fixation. Used with Corin 12/14 taper modular heads. Intended for orthopedic revision surgery; implanted by surgeons. Provides structural support for femoral reconstruction; benefits patients by restoring hip function after primary prosthesis failure.

Clinical Evidence

No clinical data. Bench testing only, including finite element analysis (FEA), mechanical fatigue testing, range of motion testing, and engineering rationales for axial/rotational disassembly and ceramic head burst strength.

Technological Characteristics

Material: Titanium alloy (Ti6 Al 4V ELI). Modular design: proximal and distal components connected via 2° 51' Morse taper and locking screw. Surface: Corundum-abraded for cementless fixation. Dimensions: Proximal (40-70mm lengths, 125°-135° angles); Distal (100-240mm lengths, 14-24mm diameters). Compatibility: Corin 12/14 taper modular heads. Single-use.

Indications for Use

Indicated for patients requiring revision surgery of femoral components following primary cemented prosthesis failure. Includes patients with non-inflammatory degenerative joint disease (osteoarthritis), rheumatoid arthritis, functional deformity, non-union, femoral neck fractures, traumatic hip dislocations, osteotomy failures, and arthrodesis.

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

• Lima MODULUS stem (K112158)
• Biomet Arcos® Modular Femoral Revision System (K100469, K090757)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Corin USA Ms. Diana L. Nader-Martone Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K152903 Trade/Device Name: REVIVAL™ Modular Revision Hip 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: March 29, 2016 Received: March 30, 2016

Dear Ms. Nader-Martone:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

# 2. INDICATIONS FOR USE

510(k) Number (if known): _K152903

Device Name: REVIVAL™ Modular Revision Hip Stem

Indications for Use:

The REVIVAL™ Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented prosthesis. The indications for the REVIVAL™ Modular Revision Hip Stem include:

- Non-inflammatory degenerative joint disease including primary and secondary . osteoarthritis
- Rheumatoid arthritis
- Correction of functional deformity ●
- Treatment of non-union and femoral neck fractures
- Treatment of traumatic dislocations of the hip ●
- Failures of osteotomy ●
- Treatment of arthrodesis

The REVIVAL™ Modular Revision Hip Stem is indicated for cementless, single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{3}------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

| 1. Applicant/Sponsor: | Corin USA |
|-------------------------|--------------------------------------------------------------|
| Distributor | 5670 W. Cypress Street |
| | Suite C |
| | Tampa, Florida 33607 |
| | Establishment Registration No.: 1056629 |
| 2. Manufacturer: | Gruppo Bioimpianti |
| | Via Liguria, 28 |
| | Peschiera Borromeo (MI) |
| | Italy |
| | Establishment Registration No: None |
| 3. Contact Person: | Diana L. Nader-Martone |
| | Regulatory Affairs Associate |
| | Corin USA |
| | 813-977-4469 |
| | [e-mail] |
| | Kathy Trier |
| | Global VP Regulatory and Clinical Affairs |
| | Corin Ltd |
| | 813-977-4469 |
| | [e-mail] |
| 4. Date: | April 27, 2016 |
| 5. Proprietary Name: | REVIVAL™ Modular Revision Hip Stem |
| 6. Common Name: | Hip Stem |
| 7. Product Code(s): | LZO, MEH |
| 8. Classification Name: | 888.3353 - Hip joint metal/ceramic/ polymer semi-constrained |

- 9. Legally Marketed Devices to which Substantial Equivalence is claimed:
cemented or nonporous uncemented prosthesis

{4}------------------------------------------------

- . Lima MODULUS stem (K112158)
- Biomet Arcos® Modular Femoral Revision System (K100469, K090757) .

## 10. Device Description:

The REVIVAL™ Modular Revision Hip Stem is a modular stem manufactured from titanium alloy (Ti6 Al 4V ELI) with a proximal component, a distal component and a locking screw. The modular proximal component is available in four lengths (40mm, 50mm, and 70mm) and two CCD angles (125° and 135°). The distal component is conical in shape and has longitudinal fins. The distal component design has four lengths (100mm, 160mm, and 240mm) and eight diameters (14mm, 16mm, 18mm, 19mm, 20mm, 22mm, and 24mm). The proximal and distal components are assembled using a 'Morse' taper 2° 51' so that the proximal component can be dialed into position to achieve the anteversion required. The locking screw is used to assemble and hold the 'Morse' taper cone in place. The REVIVAL™ Modular Revision Hip Stem has a surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation. The device is intended to be used with Corin (12/14 taper) modular heads.

## 11. Intended Use / Indications:

The REVIVAL™ Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented prosthesis. The indications for the REVIVAL™ Modular Revision Hip Stem include:

- Non-inflammatory degenerative joint disease including primary and secondary . osteoarthritis
- Rheumatoid arthritis .
- Correction of functional deformity ●
- Treatment of non-union and femoral neck fractures
- . Treatment of traumatic dislocations of the hip
- . Failures of osteotomy
- . Treatment of arthrodesis

The REVIVAL™ Modular Revision Hip Stem is indicated for cementless, single use only.

## 12. Summary of Technologies/Substantial Equivalence:

The REVIVAL™ Modular Revision Hip Stem is identical to the Biomet Arcos® Modular Femoral Revision System (K100469, K090757) in terms of material. The REVIVAL™ Modular Revision Hip Stem is similar to both the Arcos® and the Lima MODULUS stem (K112158) in indications, component design, and size ranges. All three stems utilize a modular design with a proximal femoral neck component and a distal femoral stem held together with a locking screw. Based

{5}------------------------------------------------

on these similarities, Corin believes that the REVIVAL™ Modular Revision Hip Stem is substantially equivalent to the predicate devices.

#### 13. Non-Clinical Testing:

Non-clinical testing and analysis included finite element analysis (FEA), mechanical fatique testing, and range of motion testing. Testing also included engineering rationales to demonstrate that the subject device was not a new worst-case for axial disassemble testing, rotational disassemble testing, and ceramic head burst strength testing.

#### 14. Clinical Testing:

Clinical testing was not necessary in this Traditional 510(k).

#### 15. Conclusions:

Based on the results of this testing and the design characteristics of the Corin REVIVAL™ Modular Revision Hip Stem, this device is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices.