(224 days)
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No
The 510(k) summary describes a standard hip implant system with no mention of AI, ML, image processing, or data-driven performance metrics. The testing focuses on mechanical properties.
Yes
The device is a total hip replacement system intended to alleviate severe pain and disability caused by various forms of joint disease and fractures, which falls under the definition of a therapeutic device.
No
Explanation: The device described is a hip implant, which is a prosthetic device used for reconstruction of the hip joint. It is not used to diagnose a medical condition.
No
The device description clearly outlines a physical hip implant system composed of multiple hardware components (femoral stem, femoral head, acetabular poly liner, acetabular metal). The performance studies also focus on the mechanical properties and performance of these physical components. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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 testing is done outside of the body.
- Device Description: The NovoSource hip implant components are described as a "non-cemented hip prosthesis" consisting of physical components (femoral stem, femoral head, acetabular poly liner, and acetabular metal) that are surgically implanted into the body.
- Intended Use: The intended use is for the "cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip." This is a surgical procedure involving the implantation of a medical device.
- Lack of IVD Characteristics: The description does not mention any testing of bodily specimens, analysis of biological markers, or any other activity typically associated with IVD devices.
This device is a Class III medical device (based on the nature of the implant and its intended use in replacing a major joint), which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Intended Use:
Hip joint arthroplasty
Indications for Use:
NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis
- Correction of functional deformity
- Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.
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)
Non-Clinical Testing
The NovoHip Total Hip System underwent the following testing:
- Fatigue Performance Test for NovoHip Stem
- Fatigue Performance Test for the Neck Portion of the NovoHip Stem
- Disassembly Force Test for the NovoHip Neck Taper/Femoral Head Interface
- Range of Motion Test for the NovoHip Total Hip System
- Burst Strength Test for NovoHip Ceramic Femoral Heads (Static Compression)
- Cyclic Fatigue Test for NovoHip Ceramic Femoral Heads (Cyclic Compression)
- Post-Cyclic Fatigue Burst Test for NovoHip Ceramic Femoral Heads (Static Compression)
- Pull-Off Test for NovoHip Ceramic Femoral Heads
- Rotational Stability Test for NovoHip Ceramic Femoral Heads
- Torsional Properties Test for NovoHip Bone Screws
- Driving Torque Test for NovoHip Bone Screws
- Axial Pull-Out Strength Test for NovoHip Bone Screws
- Lever-Out Test for NovoHip Acetabular Shell/Liner Assembly
- Torque-Out Test for NovoHip Acetabular Shell/Liner Assembly
- Push-In Test for NovoHip Acetabular Shell/Liner Assembly
- Push-Out Test for NovoHip Acetabular Shell/Liner Assembly
All devices met the required performance specifications for testing and are considered equivalent to the predicate devices.
Clinical Testing
No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Stelkast Provident Hip System (K935484, K033944), Smith & Nephew Biolox Delta Ceramic Femoral Head (K083762), Wright Medical Lineage Acetabular System (K002149)
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.
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510(k) Summary
FEB 2 1 2014
Applicant/Sponsor:
NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591
Contact Person:
Sharon Kvistad Navigant Consulting, LLC 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 317-228-8715 sharon.kvistad@navigant.com
Date of Preparation: February 18, 2014 .
NAME AND CLASSIFICATION
| Proposed Trade Name: | NovoHip Total Hip System |
|---|---|
| Common Name: | Hip prosthesis |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis per 21 CFR 888.3358 | |
| Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis per 21 CFR 888.3353 | |
| Device Product Code: | LPH, LZO |
| Predicate Devices: | Stelkast Provident Hip System (K935484, K033944) |
| Smith & Nephew Biolox Delta Ceramic Femoral Head (K083762) | |
| Wright Medical Lineage Acetabular System (K002149) | |
| Device Classification: | Class II |
DEVICE DESCRIPTION
The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
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K132158 page 2/3
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.
INTENDED USE
Hip joint arthroplasty
INDICATIONS FOR USE
NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
TECHNOLOGICAL CHARACTERISTICS
The NovoHip Total Hip System has the same intended use as the predicate devices. The NovoHip Total Hip System has similar indications for use as the as the predicate devices. The NovoHip Total Hip System is manufactured from the same materials as the predicate devices. The range of sizes of the NovoHip Total Hip System is similar to the predicate devices.
SUMMARY OF STUDIES
Non-Clinical Testing
The NovoHip Total Hip System underwent the following testing:
- Fatigue Performance Test for NovoHip Stem .
- Fatigue Performance Test for the Neck Portion of the NovoHip Stem ●
- . Disassembly Force Test for the NovoHip Neck Taper/Femoral Head Interface
- . Range of Motion Test for the NovoHip Total Hip System
2
- . Burst Strength Test for NovoHip Ceramic Femoral Heads (Static Compression)
- . Cyclic Fatigue Test for NovoHip Ceramic Femoral Heads (Cyclic Compression)
- Post-Cyclic Fatigue Burst Test for NovoHip Ceramic Femoral Heads (Static Compression) .
- . Pull-Off Test for NovoHip Ceramic Femoral Heads
- . Rotational Stability Test for NovoHip Ceramic Femoral Heads
- . Torsional Properties Test for NovoHip Bone Screws
- . Driving Torque Test for NovoHip Bone Screws
- . Axial Pull-Out Strength Test for NovoHip Bone Screws
- . Lever-Out Test for NovoHip Acetabular Shell/Liner Assembly
- Torque-Out Test for NovoHip Acetabular Shell/Liner Assembly .
- . Push-In Test for NovoHip Acetabular Shell/Liner Assembly
- . Push-Out Test for NovoHip Acetabular Shell/Liner Assembly
All devices met the required performance specifications for testing and are considered equivalent to the predicate devices.
Clinical Testing
No clinical testing was required.
CONCLUSION
Based on testing results and the comparisons provided, the NovoHip Total Hip System is considered substantially equivalent to the Stelkast Provident Hip System and the Wright Medical Lineage in material, construction and performance characteristics.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
February 21, 2014
Novosource, Incorporated % Ms. Sharon Kvistad Associate Director Navigant Consulting, LLC 9001 Wesleyan Road, Suite 200 Indianapolis, Indiana 46268
Re: K132158
Trade/Device Name: NovoHip Total 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, LZO Dated: January 13, 2014 Received: January 14, 2014
Dear Ms. Kvistad:
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
4
Page 2 - Ms. Sharon Kvistad
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 yours,
Vincent Dogylin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132158
Device Name: NovoHip Total Hip System
:
Indications for Use:
NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis
- Rheumatoid arthritis or traumatic arthritis .
- Correction of functional deformity .
- . Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is . unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a falled total hip arthroplasty.
Prescription Use _____X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of
Elizabet标办公Frank -S
Division of Orthopedic Devices