(295 days)
Not Found
No
The 510(k) summary describes a mechanical hip stem implant and its materials, dimensions, and performance testing related to fatigue and range of motion. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as "Total hip arthroplasty" and "intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint." These are therapeutic aims.
No
This device is an implantable hip stem used in total hip replacement surgery to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a physical hip stem made of titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a hip stem) intended for use within the human body during total hip replacement surgery. Its purpose is to replace a damaged hip joint, not to analyze biological specimens.
The device's function is mechanical and structural, not diagnostic.
N/A
Intended Use / Indications for Use
The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
- Previously failed 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
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL
Device Description
The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, proximal femoral neck
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 Test Summary: Performance testing has been conducted for the subject device Encompass® 10/12 Hip Stem in proximal fatigue in accordance with ISO 7206-6:2013 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis.
Clinical Test Summary: No clinical studies were performed.
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.
K053293, K953977, K131022, K020580
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.
Not Found
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.
0
JUN 2 0 2014
510(k) Summary
| Name of Sponsor: | Ortho Development Corporation |
|---|---|
| 12187 South Business Park Drive | |
| Draper, Utah 84020 | |
| 510(k) Contact: | Mike Ensign |
| Director of Regulatory Affairs and Quality Assurance | |
| Telephone: (801) 553-9991 | |
| Facsimile: (801) 553-9993 | |
| Email: mensign@odev.com | |
| Date Prepared: | June 19, 2014 |
| Proprietary Name: | Encompass® 10/12 Hip Stem |
| Common Name: | Hip Stem Prosthesis |
| Classification: | Class II device |
| 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained | |
| porous-coated uncemented prosthesis | |
| Device Product Code: | LPH, MBL |
| Predicate Devices: | Encompass™ Press-Fit Hip Stem (K053293) Ortho Development |
| Primaloc™ Cementless Hip System (K953977) Ortho Development | |
| Ovation 10/12 Hip Stem (K131022) Ortho Development | |
| Bi-Metric® Porous Primary Femoral Component (K020580) Biomet |
Device Description
The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.
1
Intended Use
The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
Indications for Use
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
-
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
- Previously failed surgery 2.
-
- 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 of Substantial Equivalence
The subject device Encompass® 10/12 Hip Stem is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, indications for use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization.
Non-Clinical Test Summary
Performance testing has been conducted for the subject device Encompass® 10/12 Hip Stem in proximal fatigue in accordance with ISO 7206-6:2013 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis.
Clinical Test Summary
No clinical studies were performed.
Conclusions
Based on the similarities to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K053293 and K020580.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized symbol resembling a person with outstretched arms, with three curved lines representing the body and arms. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol. The text and symbol are both in black and are set against a white background.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
June 20, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ortho Development Corporation Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020
Rc: K132697
Trade/Device Name: Encompass" 10/12 Hip Stem 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, MBL Dated: May 16, 2014 Received: May 19, 2014
Dear Mr. Haueter:
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 10 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
3
Page 2 - Mr. Tom Haueter
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 vours,
Mark N. Melkerson -A
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Explration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132697
Device Name Encompass® 10/12 Hip Stem
Indications for Use (Describe)
This device is intended for use in total 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 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
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)
:
:
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)
.
Elizabeth & Frank -S
Division of Orthopedic Devices
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