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K Number
K173880
Device Name
Corin TriFit CF Hip Stem
Manufacturer
Corin USA Limited
Date Cleared
2018-04-11

(111 days)

Product Code
MEH,KWL,KWY,LPH,LZO,MBL
Regulation Number
888.3353
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K141001,K121563,K153772
Predicate For
K241472
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • · Correction of functional deformity
  • · Treatment of non-union and femoral neck fractures of the proximal femur
  • · Developmental Dysplasia of the Hip (DDH)
  • Previously failed hip surgery

The Corin TriFit™ CF Hip Stem is indicated for cementless use only.

Device Description

The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08) applied. The Corin TriFit™ CF Hip Stem is available in a range of sizes in a 127° standard offset and a 127° lateralized high offset. The device is intended to be used with Corin 12/14 modular taper heads.

The TriFit™ CF Hip Stem is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

AI/ML Overview

This looks like a 510(k) summary for a medical device (Corin TriFit™ CF Hip Stem), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. For such submissions, clinical efficacy studies as one might find for an AI/ML device demonstrating diagnostic performance are typically not required or performed. Instead, the focus is on demonstrating substantial equivalence through non-clinical testing (e.g., mechanical properties, biocompatibility) and comparing features to existing devices.

Therefore, the specific information requested about acceptance criteria, study sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details typical for an AI/ML diagnostic device will not be found in this document.

Here's how to address your request based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or specific numerical performance metrics in the way one would expect for an AI/ML diagnostic algorithm (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to predicate devices.

Acceptance Criteria CategoryReported Device Performance (Summary from K173880)
Mechanical Performance"Mechanical fatigue testing of the neck and stem" showed the device is "expected to be safe and effective." (No specific numerical criteria or results provided in this summary).
Biocompatibility/Safety"Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology." (No specific acceptance criteria or quantitative results provided, but the implication is that it met relevant standards).
Material EquivalenceManufactured from titanium alloy (Ti6Al4V) (ASTM F136) with commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08). This is equivalent to predicate device coatings.
Design EquivalenceTapered stem design, available in standard and lateralized high offset, intended for use with Corin 12/14 modular taper heads. Neck design identical to TriFit™ TS Hip Stem (K121563, K153772).
Intended Use/Indications EquivalenceIndications for use are substantially equivalent to the predicate devices (Ortho Development Corporation Alpine Hip Stem K141001, Corin TriFit™ TS Hip K121563 and K153772).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • Sample Size for Test Set: Not applicable. This submission relies on non-clinical (mechanical, materials) testing and comparisons to predicate devices, not a test set of patient data for diagnostic performance.
  • Data Provenance: Not applicable. The "data" refers to engineering test results and design/material specifications, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

  • Not applicable. There was no "test set" requiring expert ground truth establishment for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. There was no "test set" requiring adjudication.

5. 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:

  • No. This is a medical device for hip replacement, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • No. This is a medical device for hip replacement, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Not applicable in the context of diagnostic performance. The "ground truth" for this device relates to established engineering standards for mechanical strength, material composition, and biocompatibility, as well as the safety and effectiveness profile of the predicate devices.

8. The sample size for the training set:

  • Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

  • Not applicable. This device is not an AI/ML algorithm.

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

April 11, 2018

Corin USA Limited Rachel King Regulatory Affairs Associate 12750 Citrus Park Lane Tampa, Florida 33625

Re: K173880

Trade/Device Name: Corin TriFit™ CF 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: MEH, LZO, KWL, KWY, LPH, MBL Dated: March 5, 2018 Received: March 6, 2018

Dear Ms. King:

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 Part 801); medical device 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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Indications for Use

510(k) Number (if known) K173880

Device Name Corin TriFit™ CF Hip Stem

Indications for Use (Describe) The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • · Correction of functional deformity
  • · Treatment of non-union and femoral neck fractures of the proximal femur
  • · Developmental Dysplasia of the Hip (DDH)
  • Previously failed hip surgery

The Corin TriFit™ CF Hip Stem is indicated for cementless use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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3. 510(K) SUMMARY

1. Applicant/Sponsor:DistributorCorin USA Limited12750 Citrus Park LaneSuite 120, Tampa, FL 33625Establishment Registration No.: 1056629
2. Contact Person:Rachel King, BSc (Hons)Regulatory Affairs AssociateCorin Ltd+44 1285 884733rachel.king@coringroup.comLucinda Gerber, BA (Hons)Global Regulatory Affairs ManagerCorin Ltd / Corin USA1 (772) 321-2478lucinda.gerber@coringroup.com
3. Date:December 20, 2017
4. Proprietary Name:Corin TriFit™ CF Hip Stem
5. Common Name:Hip Prosthesis
6. Product Code(s):MEH, LZO, KWL, KWY, LPH, MBL
7. Classification Name:Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis (21CFR 888.3353)Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis (21CFR 888.3390)Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis(21CFR 888.3360)

8. Legally Marketed Devices to which Substantial Equivalence is claimed:

  • Ortho Development Corporation Alpine Hip Stem (K141001) (Primary predicate) ●
  • Corin TriFit™ TS Hip (K121563 and K153772) .

Device Description: 9.

The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08) applied. The Corin TriFit™ CF Hip Stem is available in a range of sizes in a 127° standard offset and a 127° lateralized high offset. The device is intended to be used with Corin 12/14 modular taper heads.

The TriFit™ CF Hip Stem is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

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10. Intended Use / Indications:

The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • . Rheumatoid arthritis
  • . Correction of functional deformity
  • . Treatment of non-union and femoral neck fractures of the proximal femur
  • Developmental Dysplasia of the Hip (DDH)
  • . Previously failed hip surgery

The Corin TriFit™ CF Hip Stem is indicated for cementless use only.

11. Summary of Technologies / Substantial Equivalence:

The Corin TriFit™ CF Hip Stem is similar to the Ortho Development Corporation Alpine Hip Stem (K141001) stem in terms of materials, size, designs, performance, intended use and indications for use. The coating, a titanium plasma spray with a layer of calcium phosphate is identical to the TriFit™ TS Hip Stem (K121563, K153772) in terms of materials and performance. The design of the neck on the TriFit™ CF Hip Stem is identical to that of the TriFit™ TS Hip Stem (K121563, K153772). Based on these similarities, the TriFit™ CF Hip Stem is believed to be substantially equivalent to the predicate devices.

12. Non-Clinical Testing:

Non-clinical testing and analysis included mechanical fatigue testing of the neck and stem and range of motion testing. The results of this testing show that the Corin TriFit™ CF Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.

Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.

13. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the additional components of the Corin TriFit™ CF Hip Stem and the predicate devices.

§ 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.