(355 days)
No
The 510(k) summary describes a mechanical implant (acetabular cup liners) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used in total hip replacement procedures to alleviate conditions such as arthritis, avascular necrosis, and fractures, which are therapeutic interventions aimed at restoring function and reducing pain.
No
The device is an acetabular cup liner used in total hip replacement procedures, which is a therapeutic intervention, not a diagnostic one. Its purpose is to replace part of the hip joint.
No
The device description clearly states it 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 states that the device is an implant used in total hip replacement procedures. It is a physical component implanted into the body to replace a damaged joint.
- Device Description: The description details the material and manufacturing of a physical implant (acetabular cup liners).
- 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 treatment. IVDs are typically reagents, instruments, or systems used in vitro (outside the body).
This device is a medical device, specifically a prosthetic implant.
N/A
Intended Use / Indications for Use
The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K61™ 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 (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH
Device Description
The Apex HCLA™ Acetabular Cup Liners are manufactured of compression molded, cross-linked 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, 28 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): 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.
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
510(K) SUMMARY
Apex HCLA™ Acetabular Cup Liners
July 12, 2007
- 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 HCLA™ 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 HCLA 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 HCLA™ Acetabular Cup Liners are manufactured of compression molded, cross-linked 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, 28 mm diameter, with various offsets.
1
5. Predicate Device Comparison
Substantial equivalence' is claimed to the DePuy Marathon™ Cross-Linked Polyethylene Acetabular Cup Liners (K994415, K010171, and K033273). The following table summarizes the similarities and differences between the subject Apex HCLA™ Acetabular Cup Liners and the predicate DePuy Marathon™ Acetabular Cup Liners:
| | Apex HCLA™
Liners | Apex Modular
UHMWPE Liners | DePuy
Marathon™ |
|-----------------------------------------------------------------------------------|----------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------|
| 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 | Metal wire locking
ring (Duraloc
shells) or taper and
PE locking ring
(Pinnacle® shells) |
| Minimum UHMWPE
thickness (within 45°
of apex)* | 12.0 mm | 6.0 mm | 6.0 mm |
| Liner options | Neutral and 10°
hooded | Neutral, 10° and
15° hooded | Neutral and
lateralized (neutral
and face changing) |
| Head diameters | 28 mm | 28 and 32 mm | 28, 32, 36 mm |
| MATERIALS | | | |
| Cross-linked
UHMWPE | Yes | No | Yes |
| Sterilization | Ethylene oxide | Ethylene oxide | Gas plasma |
*Minimum thickness values for Apex HCLA and Apex Modular liners account for manufacturing tolerances; minimum thickness for DePuy Marathon liners is based on published product literature.
The Apex Modular HCLA 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 similar to intended use, material one one pinnacle liners, and identical to the locking mechanism in the Apex Modular UHMWPE liners (K031110). While the UHMWPE in the Apex Modular liners was not crosslinked, the cross-linked UHMWPE of the subject device is Moddlar infors woo not crosslinked UHMWPE of the predicate DePuy Marathon™ liners.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps.
AUG 1 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OMNI life science Inc. c/o Edward J. Cheal, Ph.D. Vice President of Research 175 Paramount Drive, Suite 302 Raynham, Massachusctts 02767
K062489 Trade/Device Name: Apex HCLA 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: July 12, 2007 Received: July 13, 2007
Dear Dr. Cheal:
Re:
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 (21 CFR 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 - Edward J. Cheal, Ph.D.
i his 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara McLeod
Mark N. Melkers 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): K062489
Device Name: Apex HCLA™ Acetabular Cup Liners
Indications For Use:
The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K61™ 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.
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)
Jaubere Mueup Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K062489