(118 days)
Not Found
No
The summary describes a mechanical implant (hip stem) and its physical characteristics and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral hip stem used in total and hemi-hip arthroplasty to treat various hip joint pathologies, including those caused by diseases, injuries, or prior surgeries. Its purpose is to restore the function of the hip joint.
No
Explanation: The device described is a hip stem intended for surgical implantation in total and hemi-hip arthroplasty for various hip conditions. It is a prosthetic device used for treatment, not for diagnosing an illness or condition.
No
The device description clearly states it is a "single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem" manufactured from titanium alloy. This is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a femoral hip stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to replace a damaged hip joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Entrada™ hip stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
-
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
-
- Previously failed hip surgery.
-
- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral neck fractures.
-
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
Product codes
MEH, LZO, KWY, KWL
Device Description
Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating.
The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head
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)
Non-clinical mechanical tests were conducted on the worst-case configurations of Entrada™ hip stem, including proximal fatigue, distal fatigue, and range of motion analysis. Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria. The mechanical test results demonstrate that Entrada™ hip stem is safe and effective. No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953111, K093736, K042992, K070554, K123991, K133386, K153649
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
August 24, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ortho Development Corporation Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K171249
Trade/Device Name: Entrada™ 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, KWY, KWL Dated: July 25, 2017 Received: July 27, 2017
Dear Drew Weaver:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 (DICE) 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 (DICE) 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,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171249
Device Name Entrada™ hip stem
Indications for Use (Describe)
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
-
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
-
- Previously failed hip surgery.
-
- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral neck fractures.
-
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
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3
Section 5
510(k) Summary
| Name of Sponsor: | Ortho Development® Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Drew Weaver
Director of Quality Assurance and Regulatory Affairs
Telephone: (801) 619-3419
Facsimile: (801) 553-9993
DWeaver@orthodevelopment.com |
| Date Prepared: | August 21, 2017 |
| Proprietary Name: | Entrada™ hip stem |
| Common Name: | Hydroxyapatite coated hip prosthesis |
| Classification: | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis |
| Device Product Code: | MEH, LZO, KWY, KWL |
| Class: | Class II |
| Primary Predicate Device: | Depuy Synthes Corail Hip Stem (K953111, K093736, K042992, K070554, K123991) |
| Secondary Predicate Device(s): | Ortho Development® Ovation Tribute (K133386)
Exactech Novation Element (K153649) |
Description:
Entrada™ hip stem is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads.
4
Entrada™ hip stem is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating.
The stem has a variety of sizes to accommodate the majority of patients encountered: lengths (95-160mm), horizontal offsets (35-55mm), vertical offsets (29-34mm), resection angle of 45°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.
Indications:
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
-
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post-traumatic arthritis.
-
- Previously failed hip surgery.
-
- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral neck fractures.
-
- Treatment of fractures that are unmanageable using other forms of therapy.
-
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Basis for Substantial Equivalence:
Entrada™ hip stem has the same technological characteristics as the predicate devices. These include:
-
- Indications for use
-
- Basic design
-
- Material
-
- Sizes
The following non-clinical mechanical tests were conducted on the worst-case configurations of Entrada™ hip stem:
-
- Proximal fatigue
-
- Distal fatigue
-
- Range of motion analysis
Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria.
Therefore the fundamental scientific technology of Entrada™ hip stem is the same as previously cleared devices. The mechanical test results demonstrate that Entrada™ hip stem is safe and effective. No clinical studies were performed.
Conclusions:
Based on similarities in intended use, design, materials, manufacturing methods, packaging, and the mechanical test results, the Entrada™ hip stem is substantially equivalent to the previously cleared predicate devices.