(84 days)
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- . Dislocation risk
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell:
- NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell:
The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available: - SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv.
- NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
- COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
Liner:
The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws:
When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.
This summary describes the validation of the NOVAE® Dual Mobility Acetabular Cup.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional analysis | Met specified dimensional requirements (details not provided in the document) | "acceptance criteria was met" |
| Uncemented metal-back push-out force | Met specified push-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Head insertion force and Head Pull-Out testing | Met specified insertion and pull-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Head lever out force | Met specified lever-out force requirements (details not provided in the document) | "acceptance criteria was met" |
| Number of bending cycles to flange fracture | Met specified bending cycle requirements (details not provided in the document) | "acceptance criteria was met" |
| Characterization of CP titanium and HA plasma spray | Met specified coating characteristics and integrity (details not provided in the document) | "acceptance criteria was met" |
| Range Of Motion Analysis | Met specified range of motion requirements (details not provided in the document) | "acceptance criteria was met" |
| Wear Analysis | Met specified wear performance requirements (details not provided in the document) | "acceptance criteria was met" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test. The tests were non-clinical, meaning they were likely conducted in a laboratory setting. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective data for human subjects.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. The tests are non-clinical (mechanical and material characterization), and ground truth is established by engineering specifications and standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the tests are non-clinical, there is no human interpretation or adjudication required in the same way as, for example, a clinical image review. The results are a direct measurement against predefined engineering criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (an acetabular cup for total hip replacement), not an algorithm or AI system. Therefore, the concept of standalone algorithmic performance is not relevant. The "performance" being evaluated is the mechanical and material integrity of the device itself.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on engineering specifications, material standards (e.g., ISO 5832-1:2007, ISO 5834-2:2006), and predefined acceptance thresholds for mechanical and material properties.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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AUG 2 9 2011
510(k) Summary
Date: August the 23th 2011
| Company name and address: | SERF |
|---|---|
| 85 avenue des Bruyères | |
| 69153 Décines Cedex | |
| FRANCE | |
| Phone: +33 4 72 05 60 10 | |
| Fax: +33 4 72 02 19 18 | |
| Contact person: | Caroline GELLY |
| Regulatory Affairs Engineer | |
| Date prepared: | August the 23rd, 2011 |
| Trade name: | NOVAE® Dual Mobility Acetabular Cup |
Classification name: Hip joint metal/ceramic/polymer semi-constrained cemented or
Total hip prosthesis – Acetabular component
nonporous uncemented prosthesis (21 CFR 888.3353, Product Code LZO/MEH)
Device description
Common name:
The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell:
- NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell:
The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available:
-
SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv.
-
NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
-
COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
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Liner:
The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws:
When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.
Substantial equivalence claimed to predicate devices
NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to the POLARCUP® dual mobility system (K070278, PLUS Orthopedics) in terms of intended use, design, range of sizes, materials used, mechanical safety and performances, the Restoration™ ADM system (K072020, Stryker) in terms of intended use, design and metal-back coating and the Tri-Polar system and RingLoc® + modular acetabular shell (K991990, BIOMET) in terms of intended use, design and range of sizes.
| Device | NOVAE® DualMobilityAcetabular Cup | POLARCUP® dualmobility system | Restoration™ADM System | Tri-Polar systemand RingLoc®+ modularacetabular shell |
|---|---|---|---|---|
| 510(k) number | / | K070278 | K072020 | K991990 |
| Intended use | ||||
| Total hipreplacement | Yes | Yes | Yes | Yes |
| Cementless/cemented | Yes/Yes | Yes/No | Yes/No | Yes/No |
| Primary/Revision | Yes/Yes | Yes/Yes | Yes/No | Yes/Yes |
| Design | ||||
| Dual mobility | Yes | Yes | Yes | Yes |
| Metal-back anda mobile liner | Yes | Yes | Yes | No(bipolar head +acetabular cup) |
| Screws | Cortical | Cortical | No screws | Screws |
| Pegs | Grooved | Grooved | No pegs | No pegs |
| Liner is retainedon the head | Yes | Yes | Yes | Yes |
| Materials | ||||
| Metal-back | Stainless steel (ISO5832-1:2007) | High nitrogenstainless steel (ISO5832-9:1992) | Wrought CobaltChromium alloy | Titanium alloy |
| Metal-backcoating | CP titanium and HA | CP titanium | CP titanium and HA | Titanium alloy |
| Liner | UHMWPE | UHMWPE | UHMWPE | Polyethylene |
| Pegs and Screws | Stainless steel | Stainless | Not applicable | Unknown |
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Intended use
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- . Osteoarthritis
- Femoral neck fracture .
- Dislocation risk .
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use
Non-clinical Test Summary
The following tests were conducted:
- . Dimensional analysis (acceptance criteria was met)
- . Uncemented metal-back push-out force (acceptance criteria was met)
- Head insertion force and Head Pull-Out testing (acceptance criteria was met) .
- . Head lever out force (acceptance criteria was met)
- Number of bending cycles to flange fracture (acceptance criteria was met) .
- Characterization of CP titanium and HA plasma spray (acceptance criteria was met) .
- Range Of Motion Analysis (acceptance criteria was met) .
- Wear Analysis (acceptance criteria was met)
Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical
The NOVAE® dual mobility acetabular cup is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and performance.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird or abstract design. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SERF % Mr. J.D. Webb Orthomedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
AUG 2 9 2011
Re: K111572
Trade/Device Name: NOVAE® Dual Mobility Acetabular Cup Regulation Number: 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: May 5, 2011 Received: June 6, 2011
Dear Mr. Webb:
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, 7 ug 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 1/0 hast 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
{4}------------------------------------------------
Page 2 - Mr. J.D. Webb
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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 yours,
yours,
Melkerson
Mark N. Melkerso Director Division of Surgical, Orthopedic
and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): / K\1572 (pg 1/1)
Device Name: NOVAE® Dual Mobility Acetabular Cup
Indications For Use:
NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- . Dislocation risk
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
Prescription Use (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)
for m melleer
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Orthopedic,
Division of Surgical, Orthopedic, Division of Surger
and Restorative Devices
510(k) Number
§ 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.