(126 days)
Bencox M Stem Lateralized & Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
-
Bencox M Stem Lateralized: (Sterile)
Similar to predicate device cleared under K152084. Bencox M Stem Lateralized is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head (metal and ceramic) and used with Bencox Acetabular Cups which are already cleared. When used in partial hip arthroplasty Bencox M Stem Lateralized is coupled to a Femoral Head and used with Bencox Bipolar Cup. Bencox M Stem Lateralized is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials, design, manufacturing and sterilization is essentially same as Bencox M Stem cleared under K152084 and is available in 13 sizes with CCD angle of 132°. -
Bencox Mirabo Cup System: (Sterile)
The Bencox Mirabo Cup System is a Cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. It consists of the following components:
- Acetabular Cup - Bencox Mirabo Cup
- Acetabular Liner Bencox Mirabo PE Liner
- Hole Plugs – Dome hole (same as cleared in K120924 & K150007)
- Bone Screw Bencox Bone Screw (same as cleared in K120924 & K150007) .
Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is essentially same as Bencox Mirabo Cup cleared under K120924 with respect to materials, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameters 56, 70, 72 & 74 mm.
Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner Spec. Inclusion is essentially same as Bencox Mirabo PE Liner cleared under K150007 with respect to material, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of Standard and Elevated Liners with larger head size, 40 mm.
- Bencox Hip Replacement System Instrumentation (Non Sterile)
Bencox Hip Replacement System Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of stainless steel and/or polymers and/or silicon and cleared for use in previous premarket notifications of Corentec. Bencox Hip System Instrumentation to be used Bencox M Stem Lateralized & Bencox Mirabo Cup System is same with Instrumentation cleared under K152084 , K120924 & K150007 along with the inclusion of instruments specific to Bencox M Stem Lateralized and Bencox Mirabo Cup System.
The provided text is a 510(k) summary for the "Bencox M Stem Lateralized & Bencox Mirabo Cup System," a total hip arthroplasty device. It describes the device, its indications for use, and how it demonstrates substantial equivalence to existing predicate devices.
However, the request asks for details about acceptance criteria and a study proving a device meets acceptance criteria, specifically related to performance metrics typical of AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment, sample sizes for training/test sets).
The presented document does not contain any information about AI device performance studies, clinical trials with human readers, or statistical metrics like sensitivity/specificity. It focuses on the substantial equivalence of a physical orthopedic implant (hip replacement) to previously cleared predicate devices.
The "Performance Data" section of the document primarily refers to non-clinical mechanical testing of the hip implant components (e.g., FEA, Risk Analysis, Fatigue Testing, Range of Motion Testing, Endotoxin testing) conforming to ISO and ASTM standards. This is a very different type of "performance data" than what would be presented for an AI/diagnostic device.
Therefore, I cannot fulfill your request using the provided text because it does not contain the information you are looking for regarding:
- A table of acceptance criteria and reported device performance (for an AI/diagnostic device).
- Sample sizes used for a test set and data provenance (for an AI/diagnostic device).
- Number of experts and qualifications for ground truth establishment (for an AI/diagnostic device).
- Adjudication method for the test set (for an AI/diagnostic device).
- MRMC comparative effectiveness study results (for human readers with/without AI assistance).
- Standalone AI algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for an AI/diagnostic device.
- Training set sample size (for an AI/diagnostic device).
- How ground truth for the training set was established (for an AI/diagnostic device).
The document is solely about a traditional medical device (hip prosthesis) and its mechanical and material equivalence.
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Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are arranged in a semi-circle above the symbol. The word "DEPARTMENT" is written vertically along the left side of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2016
Corentec Co., Ltd J. S. Daniel Senior Manager/Engineer - RA & QA 8F Chungho Tower, 483, Gangnam-Daero Seocho Gu Seoul, South Korea 06541
Re: K162127
Trade/Device Name: Bencox M Stem Lateralized & Bencox Mirabo Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWY Dated: October 21, 2016 Received: October 24, 2016
Dear J. Daniel:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (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.
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,
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) K162127
Device Name
Bencox M Stem Lateralized & Bencox Mirabo Cup System
Indications for Use (Describe)
Bencox M Stem Lateralized & Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
| 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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Image /page/3/Picture/1 description: The image is a logo for "Corentec Implant Specialist". The logo features the word "Corentec" in gray letters, with a red circle in the upper left corner. Below the word "Corentec" is a thin red line, and below that is the phrase "IMPLANT SPECIALIST" in smaller, gray letters.
510(K) SUMMARY Corentec Co., Ltd.
Bencox M Stem Lateralized & Mirabo Cup System 21st Nov., 2016
ADMINISTRATIVE INFORMATION
| Manufacturer | Corentec Co., Ltd.12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, South Korea-31056Telephone: +82-41-585-7114Fax: +82-41-585-7113 |
|---|---|
| Official Contact | J.S. DanielSenior Manager/Engineer – Global RA/QACorentec Co., Ltd8F Chungho Tower, 483, Gangnam-daero,Seocho Gu, Seoul, South Korea-06541Ph: +82 70 4393 3819Fax: +82 2 3445 5467Email: isdaniel@corentec.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Bencox, M Stem Lateralized & Mirabo Cup System Common Name: Hip Prosthesis 21 CFR 888.3358 Classification Regulations: Regulatory Class: II Product Codes: LPH, LZO, KWY Classification Panel: Orthopedic Products Panel Reviewing Branch: Orthopedic Devices Branch
INDICATIONS FOR USE
Bencox M Stem Lateralized & Bencox Mirabo Cup System of Bencox Hip Replacement System is intended for cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:
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Image /page/4/Picture/1 description: The image shows the "Corentec" logo. The logo consists of the word "Corentec" in gray letters, with a red circle to the left of the word. Below the word "Corentec" is a thin orange line, and below that is the phrase "IMPLANT SPECIALIST" in gray letters.
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
- d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
- e. Revision of previously failed total hip arthroplasty
DEVICE DESCRIPTION
1) Bencox M Stem Lateralized: (Sterile)
Similar to predicate device cleared under K152084. Bencox M Stem Lateralized is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head (metal and ceramic) and used with Bencox Acetabular Cups which are already cleared. When used in partial hip arthroplasty Bencox M Stem Lateralized is coupled to a Femoral Head and used with Bencox Bipolar Cup. Bencox M Stem Lateralized is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials, design, manufacturing and sterilization is essentially same as Bencox M Stem cleared under K152084 and is available in 13 sizes with CCD angle of 132°.
2) Bencox Mirabo Cup System: (Sterile)
The Bencox Mirabo Cup System is a Cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. It consists of the following components:
- Acetabular Cup - Bencox Mirabo Cup
- Acetabular Liner Bencox Mirabo PE Liner ●
- Hole Plugs – Dome hole (same as cleared in K120924 & K150007)
- Bone Screw Bencox Bone Screw (same as cleared in K120924 & K150007) .
Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is essentially same as Bencox Mirabo Cup cleared under K120924 with respect to materials, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameters 56, 70, 72 & 74 mm.
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Image /page/5/Picture/1 description: The image is a logo for "Corentec Implant Specialist". The logo features a gray semi-circle with a red circle inside of it, followed by the gray text "Corentec". Underneath the text is a thin red line, followed by the gray text "IMPLANT SPECIALIST".
Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner Spec. Inclusion is essentially same as Bencox Mirabo PE Liner cleared under K150007 with respect to material, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of Standard and Elevated Liners with larger head size, 40 mm.
3) Bencox Hip Replacement System Instrumentation (Non Sterile)
Bencox Hip Replacement System Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of stainless steel and/or polymers and/or silicon and cleared for use in previous premarket notifications of Corentec. Bencox Hip System Instrumentation to be used Bencox M Stem Lateralized & Bencox Mirabo Cup System is same with Instrumentation cleared under K152084 , K120924 & K150007 along with the inclusion of instruments specific to Bencox M Stem Lateralized and Bencox Mirabo Cup System.
SUBSTANTIAL EQUIVALENCE
- Bencox M Stem Lateralized is similar to the 510(k) cleared devices as mentioned below with respect to indications, design, specifications, operating principles and material.
| PredicateCategory | Manufacturer | Trade Name | 510(k) |
|---|---|---|---|
| Primary | Corentec | Bencox M StemLateralized | K152084 |
| Additional | DePuy | TriLock | K010367 |
The Bencox M Stem Lateralized is a wedge shaped stem with porous coating intended for press fit application similar to the predicate devices. Bencox M Stem Lateralized is manufactured from a Titanium alloy as per ASTM F136 with Commercially Pure (CP) Titanium as per ASTM F1580, coating similar to the predicate devices. Bencox M Stem Lateralized has same taper similar to the predicate device and is compatible with Corentec femoral heads and their compatible acetabular components, which have been cleared in previous premarket notifications.
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Image /page/6/Picture/1 description: The image is a logo for Corentec. The logo features the word "Corentec" in gray letters, with a red circle in the upper left corner. Below the word "Corentec" is a thin red line, and below that is the text "IMPLANT SPECIALIST" in gray letters.
- Bencox Mirabo Cup System is similar to the 510(k) cleared devices as mentioned below with respect to indications, design, specifications, operating principles and material.
| PredicateCategory | Manufacturer | Trade Name | 510(k) |
|---|---|---|---|
| Primary | Corentec | Bencox Mirabo Cup System | K120924 |
| Bencox Mirabo PE Liner | K150007 | ||
| Additional | DePuy | Pinnacle Acetabular System withALTRX Liner | K000306 &K062148 |
The subject devices Bencox Mirabo Cup System and the Bencox Mirabo Cup System (K120924) has acetabular cups made of the same material and both have plasmasprayed porous coatings with similar pore size, porosity and coating thickness. The subject and predicate acetabular cups also incorporate holes through the cup in similar positions and angulations for optional screw fixation, and both an internal taper mechanism for locking the UHMWPE liner to the cup. The Bencox Mirabo Cup System and the Bencox Mirabo PE Liner (K150007) is made of the same material, UHMWPE and cross-linked to 10 Mrad. Both incorporate a taper mechanism for locking to the acetabular cup and have standard and elevated types of Inserts Type A with angles 10°. 15°.
The Bencox Mirabo Cup system has similar dimensional specification with predicate device, Pinnacle Acetabular System, K000306 & AltrX Liner K062148.
The identified minor differences between the subject devices and predicate(s) do not constitute a new intended use and the minor differences in the technological characteristics do not affect or raise new queries of safety and effectiveness based on successful performance testing conforming to recognized performance standards for hip replacement devices.
PERFORMANCE DATA
The Bencox M Stem Lateralized & Bencox Mirabo Cup System was subjected to a series of testing protocols to document the performance of the components and to demonstrate substantial equivalence. Non-Clinical Testing and Analysis included FEA, Risk Analysis, Fatigue Testing, and Range of Motion Testing & Endotoxin testing.
The testing methods are described in the standards, ISO 7206-4, ISO 7206-6, ISO 21535 and AAMI ST72. The results of this testing showed that the subject devices are
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Image /page/7/Picture/1 description: The image shows the "Corentec" logo. The logo consists of the word "Corentec" in gray letters, with a red circle in place of the "O". Below the word "Corentec" is a thin red line, and below that is the text "IMPLANT SPECIALIST" in smaller gray letters.
expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices.
STERILIZATION & PACKAGING
For the sterile metal components - Bencox M Stem Lateralized & Bencox Mirabo Cup, following to gamma sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards which confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980. Sterilization validation as per ISO 11137-1 & 2 Sterilization of health care products - Radiation ensures sterility of the components for a SAL of 10°.
For the sterile UHMWPE components - Bencox Mirabo PE Insert, following to EtO sterilization process, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards which confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980.
Sterilization validation as per ISO 11135-1, Sterilization of health care products -Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices ensures sterility of the components for a SAL of 10°. EtO Residuals were determined according to ISO 10993-7, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. The test results are within the limits specified in ISO 10993-7.
Both Bencox M Stem Lateralized & Bencox Mirabo Cup System have same shelf life of 5 years, similar to other cleared sterile devices of Corentec. The non instruments used in the surgery must be sterilized by the hospital, prior to use, as mentioned in the IFU.
CONCLUSION
Overall, the Bencox M Stem Lateralized & Bencox Mirabo Cup System is similar to the identified primary predicate device and additional predicates. Any differences in technological characteristic between the subject and primary predicate device and additional predicate do not raise new issues of safety or efficacy and has been adequately addressed in this premarket notification.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.