(28 days)
No
The device description focuses on mechanical instruments and trials for hip arthroplasty, with no mention of AI or ML capabilities.
No
The device described is an instrumentation system for hip arthroplasty, consisting of trials and impacting parts used by surgeons to assist with the implantation of hip implants, not to directly treat or diagnose a disease or condition itself. The intended use for the overall 'BENCOX Total Hip System' refers to the hip implants being placed which are therapeutic, but this specific submission is for the tools used in the procedure.
No
The device described is a set of instruments and trials used during hip arthroplasty procedures for the implantation of a total hip system, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of Propylux and SUS, which are materials used for surgical instruments and trials. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (total or partial hip arthroplasty) to treat various conditions affecting the hip joint. This is a surgical implant and associated instrumentation, not a test performed on samples taken from the body.
- Device Description: The device consists of implants (not fully described in this excerpt, but implied by the system name) and surgical instruments (trials and impacting parts). These are physical tools used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool and implant used directly on the patient's body during a procedure.
N/A
Intended Use / Indications for Use
BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;
· Inflammatory degenerative joint disease, such as rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;
· patients with failed previous surgery where pain, deformity, or dysf unction persists;
· revision of previously failed total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWY
Device Description
The Additional components being added to the BENCOX THR System are:
- Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)
The Bencox Hip 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 Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.
The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.
The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:
Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified orthopedic surgeons
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:
- Dimensions measurement testing
The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted.
Clinical Testing:
Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence.
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.
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.
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
§ 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.
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July 14, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Corentec Co., Ltd. Sungwon Yang ()mr 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, Chungchongnam-do 31056 Korea, South
Re: K211866
Trade/Device Name: BENCOX THR 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: June 11, 2021 Received: June 16, 2021
Dear Sungwon Yang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211866
Device Name BENC0X THR System
Indications for Use (Describe)
BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;
· Inflammatory degenerative joint disease, such as rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;
· patients with failed previous surgery where pain, deformity, or dysf unction persists;
· revision of previously failed total hip arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(K) SUMMARY Corentec Co.,Ltd. BENCOX THR System
June 11th, 2021
ADMINISTRATIVE INFORMATION
Manufacturer: Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, South Korea -31056 Telephone: +82-41-585-7114; Fax: +82-41-585-7113 Official Contact: Seungri Kim Associate - RA 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, Rep. of Korea -31056 Ph: +82-41-410-7117 (Direct) ; Fax: +82-41-585-7113 Email: sr.kim(@corentec.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BENCOX THR System |
|---|---|
| Common Name: | Total Hip Joint Replacement Prosthesis |
| Classification Regulations: | 21 CFR 888.3358, 888.3353, 888.3390 |
| Class: | II |
| Product Codes: | LPH, LZO, KWY |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
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INDICATIONS FOR USE
The Indications for Use of the added specification has not changed as a result of the modification of the predicate device cleared under BENCOX THR System, K112019 & K150007 & K162127.
BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
- · non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;
- · Inflammatory degenerative joint disease, such as rheumatoid arthritis;
- · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;
- · patients with failed previous surgery where pain, deformity, or dysfunction persists;
- · revision of previously failed total hip arthroplasty.
DEVICE DESCRIPTION
The Additional components being added to the BENCOX THR System are:
- Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)
The Bencox Hip 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 Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.
The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.
The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:
Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.
5
Substantial Equivalence
BENCOX THR System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Substantially equivalent products for BENCOX THR System are as follows,
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:
| 510(k) Number | Trade or
Proprietary
Model Name | Manufacturer |
|---------------|--------------------------------------------------------|------------------|
| K162127 | Bencox M Stem
Lat. Offset
& Mirabo Cup
System | Corentec Co. Ltd |
Reference Devices Supporting Substantial Equivalence:
| 510(k) Number | Trade or
Proprietary
Model Name | Manufacturer |
|---------------|-----------------------------------------|------------------|
| K112019 | BENCOX Bipolar Cup System | Corentec Co. Ltd |
| K150007 | Modified Bencox
Mirabo
Hip System | Corentec Co. Ltd |
Summary of Technological Characteristics:
BENCOX THR System additional instrumentations performed either similar comparable predicate devices and are as safe and effective as predicate device. Any differences in
6
technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. At a high level, BENCOX THR System has the following similarities to the predicate devices:
- o has the same intended use,
- o has the same indications for use,
- o has the same operating principles,
- has the same conditions of use,
- o incorporates the same basic design
- o has the similar size, and
- o is supplied non-sterile
Non-Clinical Testing
The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence:
- . Dimensions measurement testing
The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted.
Clinical Testing
Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence.
STERILIZATION & PACKAGING
BENCOX THR System Instrumentation are supplied non-sterile and cited predicate devices are non-sterile.
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CONCLUSION
Corentec Co., Ltd. believes that the subject devices are substantially equivalent to the legally marketed predicate device based on intended use, technology, geometry as well as the non-clinical testing.