(74 days)
No
The document describes a physical medical device (acetabular cup liners) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an acetabular cup liner used in total hip replacement procedures to treat conditions such as degenerative joint disease and rheumatoid arthritis, which are therapeutic interventions.
No.
The device is an implantable prosthetic component (acetabular cup liner) used in total hip replacement procedures, not a tool for diagnosing medical conditions.
No
The device description clearly states the device is a physical implant (acetabular cup liners made of polyethylene) and does not mention any software components.
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 total hip replacement procedures. This is a medical device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details the material and manufacturing of an acetabular cup liner, which is a component of a hip prosthesis. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- e Rheumatoid arthritis:
- . Correction of functional deformity;
- . Congenital dislocation:
- . Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur. .
Product codes
LPH, LZO, MEH
Device Description
The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031110, K062489, K073150, K934765, K953490, K972774
Reference Device(s)
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
OCT 2 3 2009
Interface™ Acetabular Cup Liners
August 7. 2009
| 1. Submitter: | OMNI life scienceTM, Inc.
175 Paramount Drive
Raynham, MA 02767 |
| --------------- | ----------------------------------------------------------------------- |
|---|
- Contact: William McCallum (508) 824-2444 x423 (voice) (508) 822-6030 (fax)
2. Device Name
| Proprietary Name: | Interface™ Acetabular Cup Liners |
|---|---|
| Common Name: | Acetabular cup, uncemented |
| Classification Names: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; and |
| Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | |
| Regulatory Class: | Class II per 21 CFR §888.3358 |
3. Intended Use
The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- e Rheumatoid arthritis:
- . Correction of functional deformity;
- . Congenital dislocation:
- . Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur. .
4. Device Description
The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.
1
5. Predicate Device Comparison
Substantial equivalence is claimed to the Interface™ (K031110), the ApeX-LNK Poly™ (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Apex Modular Interface™ Acetabular System cup liners and the predicate cup liners:
| | Subject
UHMWPE
Liners | Interface™
UHMWPE Liners
(K031110) | ApeX-LNK Poly™
(K062489 and
K073150) | Zimmer Trilogy®
Acetabular
System |
|--------------------------------------------------------------|----------------------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------|
| INTENDED USE | | | | |
| Modular liner in
metal shell, primary
and revision THA | Yes, cementless | Yes, cementless | Yes, cementless | Yes, cementless |
| DESIGN | | | | |
| Liner engagement | 19° taper and PE
locking ring | 19° taper and PE
locking ring | 19° taper and PE
locking ring | Locking ring and
anti-rotation tabs |
| Liner options | 20° elevated rim | Neutral and 15°
elevated rim | Neutral and 10°
elevated rim | Neutral, 10°, and
20° elevated rim;
also offset, oblique,
and eccentric
options |
| Head diameters | 28, 32 and 36 mm | 28 and 32 mm | 28, 32, and 36 mm | 28, 32, and 36 mm |
| MATERIALS | | | | |
| Cross-linked
UHMWPE | No | No | Yes | No |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Gas plasma |
6. Basis of Substantial Equivalence
The Interface™ Acetabular Cup Liners described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. The locking mechanism is identical to the locking mechanism in the predicate Interface™ Acetabular Cup Liners (K031110) and the ApeX-LNK Poly™ Acetabular Cup Liners (K062489 and K073150). The material, manufacturing, sterilization and packaging methods are identical to those of the predicate Interface™ Acetabular Cup Liners. The 20° elevated rim liner option is equivalent to the 20° elevated rim option in the Zimmer Trilogy® Acetabular System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of three overlapping human profiles facing right, with stylized waves or lines below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OMNI Life Science, Inc. % Mr. William McCallum 175 Paramount Drive Raynham, Massachusetts 02767
Re: K092443
OCT 2 3 2009
Trade/Device Name: Interface™ Acetabular Cup Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: September 15, 2009 Received: September 18, 2009
Dear Mr. McCallum:
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.
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 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.
3
Page 2- Mr. William McCallum
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Interface™ Acetabular Cup Liners
Indications For Use:
The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2TM, or Apex K1™ Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis: .
- ◆ Correction of functional deformity;
- . Congenital dislocation:
- Revision procedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur. .
Prescription Use X (Per 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)
Sonita 2 for MXN
ision Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092443
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