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.

AI/ML Overview

Medical device documentation, such as the provided FDA 510(k) submission, typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance data in the same way one might for an AI/ML software device or a diagnostic test.

In this context, the "acceptance criteria" for a medical device like the REVIVAL™ Modular Revision Hip Stem are met by demonstrating that it is as safe and effective as a legally marketed predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing and engineering rationales provided to support this substantial equivalence.

Based on the provided text, here's a breakdown of the requested information, adapted to fit the context of a medical implant 510(k) submission:

Acceptance Criteria and Device Performance (Adapted for a 510(k) Submission)

Since this is a 510(k) for a hip stem, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices regarding safety, effectiveness, and performance. The "reported device performance" is primarily based on non-clinical testing showing mechanical integrity and design similarities.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices)	Reported Device Performance (Summary of Non-Clinical Testing)
Material Equivalence: Material composition should be comparable to predicate devices.	The REVIVAL™ Modular Revision Hip Stem is "identical to the Biomet Arcos® Modular Femoral Revision System (K100469, K090757) in terms of material" (titanium alloy (Ti6 Al 4V ELI)).
Design and Indications Equivalence: Component design, size ranges, and indications for use should be similar to predicate devices.	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 utilize a modular design with a proximal femoral neck component and a distal femoral stem held together with a locking screw. Indications for Use are clearly listed and comparable to those for predicate devices.
Mechanical Performance: Device should meet or exceed mechanical performance standards of predicate devices, demonstrating structural integrity and fatigue resistance.	Non-clinical testing included: - Finite Element Analysis (FEA) - Mechanical Fatigue Testing - Range of Motion Testing - Engineering rationales demonstrated the subject device was not a new worst-case for axial disassembly testing, rotational disassembly testing, and ceramic head burst strength testing.
Fixation Mechanism: Demonstrate effective fixation.	Surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation.

Detailed Study Information (Adapted for a 510(k) Submission)

Given that this is a 510(k) for a medical implant and not a software/diagnostic device, many of the requested fields (e.g., sample size for test set, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable in their original sense. The evaluation relies on non-clinical testing and comparison to predicate devices, not clinical studies or AI algorithm performance.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data for this 510(k). The "test set" here refers to physical prototypes of the device used for non-clinical mechanical testing. The exact number of prototypes/samples used for each non-clinical test (FEA, mechanical fatigue, range of motion, disassembly, burst strength) is not specified in this document. These would be standard engineering test samples.
- Data Provenance: The non-clinical testing was conducted either internally by the manufacturer (Gruppo Bioimpianti, Italy) or by a qualified third-party testing facility. The document doesn't specify the exact location of the testing, but the manufacturer is based in Italy. The data is prospective, generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology for a diagnostic device. For a hip stem, the "truth" is established through engineering and biomechanical principles verified by testing, and by comparison to the known performance of predicate devices. The "experts" involved are likely biomechanical engineers and regulatory specialists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are usually for human interpretation of clinical data. For non-clinical testing, results are typically evaluated against pre-defined engineering standards or comparative data from predicate devices.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (hip stem), not an AI/ML software or diagnostic imaging device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's safety and effectiveness is established through a combination of:
  - Engineering Principles and Standards: Compliance with industry-recognized standards for materials, design, and mechanical performance.
  - Predicate Device Performance: The known long-term clinical performance and safety profile of the legally marketed predicate devices (Biomet Arcos® Modular Femoral Revision System and Lima MODULUS stem).
  - Physical Testing Results: Data from non-clinical tests (FEA, fatigue, range of motion, disassembly, burst strength) demonstrating that the new device performs acceptably and is comparable to or better than the predicate devices in critical mechanical aspects.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this traditional 510(k) for a hip stem. Design and engineering are based on established biomechanical principles and predicate device designs, not machine learning training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the overall device development and validation is derived from engineering standards, biomechanical science, and the clinical history of predicate devices.

Summary

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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

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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

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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

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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

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. 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

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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.

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.