K Number

Device Name

REVIVAL(TM) Modular Revision Hip Stem

Manufacturer

CORIN USA

Date Cleared

2016-04-29

(211 days)

Product Code

LZO MEH

Regulation Number

888.3353

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K112158, K100469, K090757

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the mechanical components and materials of a modular hip stem, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical mechanical tests.

Therapeutic

Yes
The device is a modular hip stem intended for revision surgery to correct functional deformity, treat non-union, fractures, dislocations, and failures of osteotomy, which are all conditions that impair normal body function and require intervention to restore health and function.

Diagnostic

No
This device is a modular hip stem intended for revision surgery of femoral components. It is an implant designed for treatment, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly details a physical, implantable hip stem made of titanium alloy with various components (proximal, distal, locking screw). It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The description clearly states that the REVIVAL™ Modular Revision Hip Stem is a physical implantable device made of titanium alloy, designed for surgical implantation in the hip.
Intended Use: The intended use is for revision surgery of femoral components, addressing issues like osteoarthritis, rheumatoid arthritis, fractures, and dislocations. This is a surgical procedure, not a diagnostic test performed on a sample.

The device is a surgical implant, not a diagnostic tool used outside the body on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LZO, MEH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

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

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.

K112158, K100469, K090757

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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. INDICATIONS FOR USE

510(k) Number (if known): _K152903

Device Name: REVIVAL™ Modular Revision Hip Stem

Indications for Use:

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

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
	diana.nader-martone@coringroup.com
	Kathy Trier
	Global VP Regulatory and Clinical Affairs
	Corin Ltd
	813-977-4469
	kathy.trier@coringroup.com
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

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

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

10. Device Description:

11. Intended Use / Indications:

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

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

13. Non-Clinical 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.