(122 days)
No
The summary describes a mechanical hip implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip system explicitly intended for use in total or partial hip arthroplasty to treat various degenerative joint diseases, fractures, and failed previous surgeries, which clearly indicates a therapeutic purpose.
No
This device is not a diagnostic device. It is an orthopedic implant system (Modified Bencox Hip System) used for total or partial hip arthroplasty, which is a surgical procedure to replace damaged parts of the hip joint. Its purpose is treatment, not diagnosis.
No
The device description clearly lists physical components (Acetabular Insert, Femoral Stem, Femoral Head, Instrumentation) which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various hip conditions through arthroplasty. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Device Description: The device components are physical implants (acetabular insert, femoral stem, femoral head) and associated surgical instrumentation. These are used to replace or repair damaged hip joints, not to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device is a surgical implant used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The Modified Bencox Hip System is intended for 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 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
Product codes
LPH, KWY, LZO
Device Description
The Modified Bencox Mirabo Hip System consists of the following components,
- Acetabular Insert Bencox Mirabo PE Liner (Std. & Elevated), .
- Femoral Stem Bencox ID Stem (Offset), .
- Femoral Head Bencox Delta Head (XL), ●
- Instrumentation Bencox Total Hip System Instrumentation. .
The components are modification of Acetabular Insert cleared in K120924 (& K103431), Femoral Stem cleared in K112019 & specification inclusion of Femoral Heads cleared in K121665. The modified components are cementless, metal-onpolyethylene hip system for hip arthroplasty similar to devices cleared in respective mentioned 510(k)'s.
Modified Bencox Mirabo PE Liner is manufactured from similar material cleared under K120924 & K103431, conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation similar to predicate device Bencox Mirabo PE Liner and other predicates such as Stryker Crossfire.
Modified Bencox ID Stem (Offset) is similar to the predicate device Bencox ID Stem cleared in K112019, except for the slightly thicker neck geometry and horizontal offset.
Bencox Delta Head XL specification inclusion consists of diameters 32, 36 & 40 mm design is similar to the 510k cleared devices, Bencox Delta Head (K121665). The specification is also similar with other predicate devices and has the same supplier, CeramTec, AG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Performance testing for modified Bencox Mirabo PE Insert was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 14242, ASTM F1820 and ASTM F2582. Mechanical testing of the subject device consisted of wear, liner torsion & lever out, push out and impingement testing. The acetabular cup system performed comparable to the predicate devices. Material characterization as per ASTM 2565 was carried out and obtained values of various parameters were comparable to predicate devices.
Performance testing for modified Bencox ID Stem (Offset) with worst case combination of Bencox Delta Head XL, 40 mm and was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 7204-4, ISO 7204-6. Mechanical testing of the subject device consisted of fatigue and range of motion testing. The femoral stem satisfied the standards and performed similar to predicate devices.
Performance testing with respect to Bencox Delta Heads XL refers to predicate device submission, K121665 and CeramTec Device Master File.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120924, K103431, K112019, K121665
Reference Device(s)
K974685, K021911, K043537, K112115, K071535
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, black line drawing style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2015
Corentec Company, Limited Mr. J.S. Daniel Senior Manager/Engineer - RA/QA 8F Chungho Tower, 483 Gangnam-daero, Seocho Gu Seoul 137-040 Republic of Korea
Re: K150007
Trade/Device Name: Modified Bencox Hip 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, KWY, LZO Dated: April, 1, 2015 Received: April 2, 2015
Dear Mr. J.S. 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
1
Page 2 - Mr. J.S. Daniel
(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 (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" (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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INDICATIONS FOR USE
510(k) Number (if known): K150007 (page 1/1)
Device Name: Modified Bencox Hip System
The Modified Bencox Hip System is intended for 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 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
Prescription Use: X (Per 21 CFR 801 Subpart D) AND / OR
Over-The Counter Use :-(Per 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)
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510(K) SUMMARY Corentec Co., Ltd. Modified Bencox Hip System 3156 Dec., 2014
ADMINISTRATIVE INFORMATION
| Manufacturer | Corentec Co., Ltd. |
|---|---|
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | |
| Cheonan-si, Chungchongnam-do, 331-822 South Korea | |
| Telephone: +82-41-585-7114 | |
| Fax: +82-41-585-7113 | |
| Official Contact | J.S. Daniel |
| Senior Manager/Engineer - RA/QA | |
| Corentec Co., Ltd | |
| 8F Chungho Tower, 483, Gangnam-daero | |
| Seocho Gu, Seoul, Korea 137-040 | |
| Ph: +82 70 4393 3819 | |
| Fax: +82 2 3445 5467 | |
| Email: jsdaniel@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Modified Bencox Mirabo Hip System |
|---|---|
| Common Name: | Total Hip Prosthesis System |
| Classification Regulations: | 21 CFR 888.3358; 888.3390; 888.3353 |
| Class: | II |
| Product Codes: | LPH, KWY, LZO |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
The Modified Bencox Hip System is intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
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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
[The intended use of the modified devices of modified Bencox Hip System has not changed as a result of the modification of the predicate devices, cleared under, K120924 (K103431), K112019 & K121665]
DEVICE DESCRIPTION
The Modified Bencox Mirabo Hip System consists of the following components,
- Acetabular Insert Bencox Mirabo PE Liner (Std. & Elevated), .
- Femoral Stem Bencox ID Stem (Offset), .
- Femoral Head Bencox Delta Head (XL), ●
- Instrumentation Bencox Total Hip System Instrumentation. .
The components are modification of Acetabular Insert cleared in K120924 (& K103431), Femoral Stem cleared in K112019 & specification inclusion of Femoral Heads cleared in K121665. The modified components are cementless, metal-onpolyethylene hip system for hip arthroplasty similar to devices cleared in respective mentioned 510(k)'s.
Modified Bencox Mirabo PE Liner is manufactured from similar material cleared under K120924 & K103431, conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation similar to predicate device Bencox Mirabo PE Liner and other predicates such as Stryker Crossfire.
Modified Bencox ID Stem (Offset) is similar to the predicate device Bencox ID Stem cleared in K112019, except for the slightly thicker neck geometry and horizontal offset.
Bencox Delta Head XL specification inclusion consists of diameters 32, 36 & 40 mm design is similar to the 510k cleared devices, Bencox Delta Head (K121665). The specification is also similar with other predicate devices and has the same supplier, CeramTec, AG.
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SUBSTANTIAL EQUIVALENCE
Modified Bencox Hip 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, as below,
| Manufacturer | Trade Name | 510(k) |
|---|---|---|
| Bencox Mirabo PE Insert | ||
| Corentec Co., Ltd. | Bencox Mirabo Cup System & | |
| Bencox (Coren) Total Hip System | K120924 & | |
| K103431 | ||
| Osteonics / Howmedica | ||
| Osteonics Corp. | Osteonics (Crossfire) PE Acetabular | |
| Components & Trident Acetabular | ||
| System | K974685 & | |
| K021911 | ||
| Bencox ID Stem (Offset) | ||
| Corentec Co. Ltd. | Bencox ID Stem | K112019 |
| Biomet | Taperloc | K043537 |
| Bencox Delta Heads XL | ||
| Corentec Co., Ltd. | Bencox Forte & Bencox Delta | K121665 |
| MEDACTA | ||
| International SA | MectaCer Biolox Delta Heads | K112115 |
| Zimmer, Inc | Biolox delta Ceramic Femoral Head | K071535 |
PERFORMANCE DATA
Performance testing for modified Bencox Mirabo PE Insert was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 14242, ASTM F1820 and ASTM F2582. Mechanical testing of the subject device consisted of wear, liner torsion & lever out, push out and impingement testing. The acetabular cup system performed comparable to the predicate devices. Material characterization as per ASTM 2565 was carried out and obtained values of various parameters were comparable to predicate devices.
6
Performance testing for modified Bencox ID Stem (Offset) with worst case combination of Bencox Delta Head XL, 40 mm and was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 7204-4, ISO 7204-6. Mechanical testing of the subject device consisted of fatigue and range of motion testing. The femoral stem satisfied the standards and performed similar to predicate devices.
Performance testing with respect to Bencox Delta Heads XL refers to predicate device submission, K121665 and CeramTec Device Master File.
Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.
Overall, the modified Bencox Hip System components included in this submission has similarities to the predicate devices with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile.