(85 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the hip implant components, with no mention of AI/ML algorithms or data processing.
Yes
The device is described as an artificial hip joint component (Delta Option Heads of BENCOX Total Hip System) intended for use in total or partial hip arthroplasty to treat various degenerative joint diseases, fractures, and failed previous surgeries, which are conditions addressed by therapeutic interventions.
No
Explanation: The device described is a hip prosthesis component (femoral head) used in hip arthroplasty for treatment of various hip conditions. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (ball head, titanium sleeve) made of specific materials (BIOLOX® delta ceramic, Ti6Al4V). The performance studies also focus on physical properties and testing of these components (Burst Testing, Fatigue Testing, etc.), indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip prosthesis head and its assembly. This is consistent with a medical device used in vivo (within the body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies listed are related to the mechanical and material properties of the implant (burst testing, fatigue testing, corrosion testing, etc.), which are relevant for a surgical device, not an IVD.
- No Mention of Diagnostic Output: There is no indication that this device produces any diagnostic results or information about a patient's health status based on analyzing biological samples.
In summary, the BENCOX Delta Option Heads of BENCOX Total Hip System is a surgical implant designed to replace or augment a damaged hip joint, which falls under the category of a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial 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 trochanteric 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
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY
Device Description
The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.
The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.
The design features and materials of the subject device, BENCOX Delta Option head are substantially equivalent to BIOLOX® delta Option devices cleared under K192683 and K173776 since the subject device is supplied by CeramTec.
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
Not Found
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)
The following tests were performed on the BENCOX Delta Option Heads to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- . Burst Testing
- . Fatigue Testing
- · Post-fatigue Burst Testing
- . Pull-off Testing
- . Torque-out Testing
- . Range of Motion
- . Corrosion Testing and Assessment
Pyrogen testing was conducted in accordance with USP, and ANSI/AAMI ST72 to ensure the proposed BENCOX Delta Option Heads meet recommended limits per FDA's Guidance Document submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 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.
0
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March 16, 2023
Corentec Co., Ltd. Yoorim Bae RA Specialist 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea
Re: K223828
Trade/Device Name: BENCOX Delta Option Heads 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, KWY Dated: December 12, 2022 Received: December 21, 2022
Dear Yoorim Bae:
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.
1
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) 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 mediation-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.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223828
Device Name BENCOX Delta Option Heads
Indications for Use (Describe)
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial 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 trochanteric 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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3
510(k) SUMMARY
(As required by 21 CFR 807.92)
Date: March 15, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, Rep. of Korea -31056
Telephone: +82-41-585-7114; Fax: +82-41-585-7113 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Yoorim Bae
RA Specialist
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, Rep. of Korea -31056
Ph: +82-41-410-7116 (Direct) ; Fax: +82-41-585-7113 |
Email: yoorim.bae@corentec.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BENCOX Delta Option Heads |
|---|---|
| Common Name: | Femoral Head Prosthesis |
| Regulation and Classification Name: | 21 CFR 888.3353 |
| Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis | |
| Regulatory Class: | Class II |
| Product Codes: | LZO, KWY |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:
| Primary Devices Supporting Substantial Equivalence: | ||
|---|---|---|
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, | |
| BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH | |
| Reference Devices Supporting Substantial Equivalence: | ||
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
| K121665 | BENCOX Forte & BENCOX Delta | Corentec Co., Ltd. |
| K173776 | BIOLOX delta Option and Extra-long Heads | MicroPort |
| Orthopedics Inc. | ||
| K103012 | Exactech BIOLOX®Delta Femoral Heads and | |
| BIOLOX® Option Femoral Heads and Adapters | Exactech, Inc. |
4
Indications For Use
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial 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 trochanteric 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
Purpose and Device Description
The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.
The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.
The design features and materials of the subject device, BENCOX Delta Option head are substantially equivalent to BIOLOX® delta Option devices cleared under K192683 and K173776 since the subject device is supplied by CeramTec.
Summary of Technological Characteristics
Device Comparisons and performance testing indicate that the BENCOX Delta Option Heads are substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
Non-Clinical Studies
The following tests were performed on the BENCOX Delta Option Heads to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- . Burst Testing
- . Fatigue Testing
- · Post-fatigue Burst Testing
- . Pull-off Testing
- . Torque-out Testing
- . Range of Motion
- . Corrosion Testing and Assessment
5
Pyrogen testing was conducted in accordance with USP, and ANSI/AAMI ST72 to ensure the proposed BENCOX Delta Option Heads meet recommended limits per FDA's Guidance Document submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of