(116 days)
No
The summary describes a mechanical hip implant and its components, with performance studies focused on mechanical testing and engineering analyses. There is no mention of AI or ML.
Yes.
Explanation: The device is a Novation LPI Prime Femoral Stem for hip replacement, which is considered a therapeutic device as it treats conditions like osteoarthritis, rheumatoid arthritis, and osteonecrosis.
No
Explanation: The device is a Novation LPI Prime Femoral Stem, which is a hip prosthesis designed for surgical implantation. Its "Intended Use / Indications for Use" specifies its role in hip replacement surgery, not in diagnosing medical conditions.
No
The device description clearly describes a physical femoral stem prosthesis, which is a hardware component. The performance studies also focus on mechanical testing of this hardware.
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 hip replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "femoral stem," a physical prosthesis implanted into the femur.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo surgical implant.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, LPH
Device Description
The Novation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with porous titanium plasma spray for uncemented, biological fixation.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- Exactech Cobalt Chromium Alloy Femoral Heads (K041906) .
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) .
- Exactech BIOLOX®forte Alumina Femoral Heads (K032964, K051682) .
- Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
- AcuMatch L-series Unipolar endoprosthesis (K010081)
The proposed femoral stems are intended to mate with the following bipolar components: - AcuMatch L-Series Bipolar Endoprosthesis (K013211) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Proximal Femur
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
surgeon
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)
Results from mechanical testing, engineering analyses, simulated surgical implantations and literature reviews demonstrate the proposed Novation LPI Prime Femoral Stems are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- Clinical Literature Review of similar femoral prostheses
- Cadaver lab validation demonstrating the design features (including outside geometry and overall scope).
- Finite Element Analyses for determination of worst case size for testing. t
- Range of Motion testing per EN ISO 21535, Non-active surgical implants --. Joint replacement implants -- Specific requirements for hip-joint replacement implants
- Distally Fixed Fatigue Worst case Press-fit Fatigue Testing per FDA guidance
- Femoral Neck Fatigue Worst case Press-fit Fatigue Testing per FDA guidance
- Femoral Head Modular Junction Burst Testing and Axial pull-off Testing on . the taper specification
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.
K041906, K050398, K060107, K032964, K051682, K103012, K010081, K013211
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
121684 Exactech® Novation® LPI Prime Femoral Stem Traditional 510(k)
510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville FL, 32653 |
|-----------------|---------------------------------------------------------------|
| Date: | September 24, 2012 |
| Contact Person: | Vladislava Zaitseva |
Vladislava Zaitseva Contact Person: Regulatory Affairs Specialist II Telephone: (352) 327-4674 Fax: (352) 378-2617
Exactech® Novation® LPI Prime Femoral Stem Proprietary Name:
Femoral Hip Stem Common Name:
Classification Name:
A - France
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR Section 888.3353, Class II, Product Code LZO)
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (21 CFR Section 888.3390, Class II, Product Code KWY)
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358, Device Class: II, Product Code: LPH)
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Metha Short Stem Hip System | Aesculap | K080584 and K112682 |
Device Description
The Novation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with porous titanium plasma spray for uncemented, biological fixation.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- Exactech Cobalt Chromium Alloy Femoral Heads (K041906) .
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) .
- Exactech BIOLOX®forte Alumina Femoral Heads (K032964, K051682) .
- Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
- AcuMatch L-series Unipolar endoprosthesis (K010081)
Ocr
1 2012
1
The proposed femoral stems are intended to mate with the following bipolar components:
- AcuMatch L-Series Bipolar Endoprosthesis (K013211) .
Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use. The proposed Novation LPI Prime Femoral Stems and . predicate devices have similar indications for use.
- Materials. The proposed Novation LPI Prime Femoral Stems and predicate . devices are composed of materials conforming to recognized industry standards for permanent implants.
- Sterilization processes. The proposed Novation LPI Prime Femoral Stems ● and predicate devices are provided sterile for single use and conform to recognized industry standards.
- Design Features. The proposed Novation LPI Prime Femoral Stems and . predicate devices incorporate similar design features.
- Performance specifications. The proposed Novation LPI Prime Femoral . Stems and predicate devices conform to recognized performance standards for total hip replacement devices.
Substantial Equivalence Conclusion
Results from mechanical testing, engineering analyses, simulated surgical implantations and literature reviews demonstrate the proposed Novation LPI Prime Femoral Stems are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- Clinical Literature Review of similar femoral prostheses .
- Cadaver lab validation demonstrating the design features (including outside . geometry and overall scope).
- Finite Element Analyses for determination of worst case size for testing. t
2
Image /page/2/Picture/0 description: The image shows the text "K121684" at the top. Below that, the text "Exactech® Novation® LPI Prime Femoral Stem" is displayed. The last line of text says "Traditional 510(k)". The image appears to be a label or identifier for a medical device, specifically a femoral stem.
- Range of Motion testing per EN ISO 21535, Non-active surgical implants --. Joint replacement implants -- Specific requirements for hip-joint replacement implants
- Distally Fixed Fatigue Worst case Press-fit Fatigue Testing per FDA guidance .
- Femoral Neck Fatigue Worst case Press-fit Fatigue Testing per FDA guidance .
- Femoral Head Modular Junction Burst Testing and Axial pull-off Testing on . the taper specification
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming a stylized staff with a serpent entwined around it. The text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exactech, Incorporated % Ms. Vladislava Zaitseva Regulatory Affairs Specialist II 2320 NW 66th Court Gainesville, Florida 32653
OCT
1 2012
Re: K121684
Trade/Device Name: Exactech® Novation® LPI Prime Femoral 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, LZO, KWY Dated: September 11, 2012 Received: September 12, 2012
Dear Ms. Zaitseva:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Ms. Vladislava Zaitseva
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Novation® LPI Prime Femoral Stem
Traditional 510(k)
Indications for Use
510(k) Number:
1/2/684
Device Name: Exactech® Novation® LPI Prime Femoral Stem
INDICATIONS FOR USE:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Over-The-Counter Use and/or X Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ast
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121684