(111 days)
Not Found
No
The summary describes a mechanical implant (acetabular cup liners) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is an acetabular liner for total hip replacement procedures, which is explicitly described as a prosthesis. Prostheses are therapeutic devices.
No
The device description clearly states it is an acetabular cup liner, which is a prosthesis used in total hip replacement procedures, not a tool for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is manufactured from "compression molded, crosslinked and stabilized ultrahigh molecular weight polyethylene," indicating it is a physical implant, not software.
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 therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and manufacturing of a physical implant (acetabular cup liners). This is consistent with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a prosthetic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The ApeX-LNK Poly™ Acetabular Cup Liners are intended for use with the Apex Modular™ 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;
- 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 ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, crosslinked and stabilized 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, 32 mm diameter, with various offsets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Apex Modular (K031110), Apex HCLA (K062489), DePuy Marathon™ (K994415, K010171, and K033273), DePuy AltrX™ acetabular cup liners (K062148)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K073150 (pg. 1 of 2)
510(K) Summary
FED 27 ....
ApeX-LNK Poly™ Acetabular Cup Liners
November 7, 2007
| 1. Submitter: | OMNI life science™, Inc.
175 Paramount Drive
Raynham, MA 02767 |
|---------------|----------------------------------------------------------------------------|
| Contact: | Edward Cheal, Ph.D.
(508) 824-2444 x413 (voice)
(508) 822-6030 (fax) |
2. Device Name
| Proprietary Name: | ApeX-LNK Poly™ 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 §888.3353 and 21 CFR §888.3358 |
3. Intended Use
The ApeX-LNK Poly™ Acetabular Cup Liners are intended for use with the Apex Modular™ 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;
- 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 ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, crosslinked and stabilized 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, 32 mm diameter, with various offsets.
1
K073150 (pg. 2 of 2)
510(K) Summary
5. Predicate Device Comparison
Substantial equivalence is claimed to the Apex Modular (K031110), the Apex HCLA (K062489), the DePuy Marathon™ (K994415, K010171, and K033273), and the DePuy AltrX™ acetabular cup liners (K062148). The following table summarizes the similarities and differences between the subject ApeX-LNK Poly™ Acetabular Cup Liners and the predicate Apex HCLA, the DePuy Marathon and the DePuy AltrX Acetabular Cup Liners:
| | ApeX-LNK Poly
Liners | Apex HCLA
Liners | DePuy Marathon
and AltrX | |
|----------------|-----------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------|----------------------------------------------------|
| INTENDED USE | Modular liner in
metal shell, primary
and revision total hip
replacement | Yes, cementless | Yes, cementless | Yes, cemented and
cementless |
| DESIGN | Liner engagement | 19° taper and PE
locking ring | 19° taper and PE
locking ring | Taper and PE
locking ring
(Pinnacle® shells) |
| Liner options | Neutral and 10°
hooded | Neutral and 10°
hooded | Neutral and
lateralized (neutral
and face changing) | |
| Head diameters | 32 and 36 mm | 28 mm | 28, 32, 36 mm | |
| MATERIALS | Cross-linked
UHMWPE | Yes | Yes | Yes |
| Sterilization | Ethylene oxide | Ethylene oxide | Gas plasma | |
6. Basis of Substantial Equivalence
The ApeX-LNK Poly 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 Apex Modular Acetabular Cup Liners (K031110) and the Apex HCLA Acetabular Cup Liners (K062489). The material, manufacturing, sterilization and packaging methods are identical to those of the Apex HCLA Acetabular Cup Liners.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is in black and white.
FEB 27 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OMNI Life Science™, Inc. % Dr. Edward Cheal Vice President of Research and Development 175 Paramount Drive Raynham, MA 02767
Re: K073150 Trade/Device Name: ApeX-LNK PolyTM Acetabular Cup Liners 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, MEH Dated: February 4, 2008 Received: February 5, 2008
Dear Dr. Cheal:
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 such 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 (21CFR Part 807); labeling (21 CFR Part 801); 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 - Dr. Edward Cheal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073150
Device Name: ApeX-LNK Poly™ Acetabular Cup Liners
Indications For Use:
The ApeX-LNK Poly Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, 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)
Barbara Buchner
Page 1 of 1
sion of General, Restorative. and Neurological Devices
510(k) Number K073150