(28 days)
No
The document describes a mechanical hip replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a hip replacement system, specifically an acetabular cup liner and femoral heads, intended for treating various joint conditions by replacing parts of the hip joint. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a hip implant system, specifically acetabular cup liners and femoral heads, intended for total hip replacement procedures to treat various joint conditions. It is a prosthetic device used for treatment, not for diagnosing conditions.
No
The device description clearly indicates that the device is a physical implant (acetabular cup liners and femoral heads) made of materials like polyethylene oxide, cobalt chrome, and alumina ceramic. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a hip replacement system, including femoral stems, acetabular cups, and liners. These are implantable medical devices used in surgery to replace damaged hip joints.
- Intended Use: The intended use clearly states that the system is for "primary and revision total hip replacement" to treat various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat the following conditions, as apropriate:
- · 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
LZO, MEH, LPH
Device Description
ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.
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
orthopaedic surgeon / 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)
Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAR 2 9 2010
ApeX-LNK Poly™ Acetabular Cup Liners Apex Modular Heads
March 09, 2010
- Submitter: OMNI life science™, Inc. 50 O'Connell Way, Suite#10 E. Taunton,MA 02718
Contact: Radhika Pondicherry, Regulatory Affairs 774-226-1842 (508) 822-6030 (fax)
2. Device Name: The device trade names and common/classification names are-
| Device Trade Name | Common/Classification name |
|---|---|
| ApeX-LNK Poly™ Acetabular Cup Liners | Hip joint metal/ Acetabular cup Liner, uncemented |
| Hip joint metal/ceramic/polymer semi-constrained cemented | |
| or nonporous uncemented prosthesis | |
| Apex Modular Head | Hip joint metal/polymer/metal semi-constrained porous- |
| coated uncemented prosthesis |
Device Class
Acetabular Liners and Femoral Heads have been classified as Class II 21 CFR §888.3353, Product Code LZO, MEH 21 CFR §888.3358, Product Code LPH These products are reviewed by the Orthopedic Devices panel
3. Intended use
=
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat the following conditions, as apropriate:
- · 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
ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
1
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.
5. Predicate Device Comparison
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. .
| Description | Predicate Device Comparison | ||
|---|---|---|---|
| ApeX-LNK | |||
| (subject device) | ApeX-LNK | ||
| (K073150) | |||
| INTENDED USE | |||
| Modular liner in metal shell, primary and revision THA | Yes, cementless | Yes, cementless | |
| DESIGN | |||
| Liner engagement | 19° taper and PE locking ring | 19° taper and PE locking ring | |
| Liner options | Neutral and 10° hooded | Neutral and 10° hooded | |
| Head diameters | 40 mm | 28, 32, and 36 mm | |
| MATERIALS | |||
| Cross-linked UHMWPE | Yes | Yes | |
| Standards | ASTM F648 | ASTM F648 | |
| PACKAGING & STERILIZATION | |||
| Sterilization | Ethylene oxide | Ethylene oxide | |
| SAL | 10-6 | 10-6 | |
| Packaging | Paper board box, Foil outer pouch, Double Tyvek inner pouch | Paper board box, Foil outer pouch, Double Tyvek inner pouch | |
| Apex Modular Femoral Heads | |||
| Apex Modular Femoral Heads (subject device) | Apex Modular Femoral Heads | ||
| (K000788) | |||
| Intended Use | |||
| Primary and revision total hip replacement | Yes | Yes | |
| Design | |||
| Taper Design | Identical (size "N" bore in ASTM F1636-95) | Identical (size "N" bore in ASTM F1636-95) | |
| Head Diameters | 40 mm | 22.225, 28, and 32 mm | |
| Offsets | -3.5, +0, +3.5, +7 | -3.5, +0, +3.5, +7 | |
| Materials | |||
| Femoral Heads | Wrought cobalt chromium | ||
| (ASTM F1537) | Wrought cobalt chromium | ||
| (ASTM F1537) | |||
| Standards | ASTM F1537 | ASTM F1537 | |
| PACKAGING AND | |||
| STERILIZATION | |||
| Sterilization | Ethylene oxide | Ethylene oxide | |
| Sal | 10-6 | 10-6 | |
| Packaging | Paper Board Box, Double | Paper Board Box, Double Tyvek |
2
6. Basis of Substantial Equivalence
The ApeX-LNK Poly Acetabular Cup Liners and Apex Modular Heads described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices.
The modified ApeX-LNK Acetabular Cup Liners and Apex Modular Heads have the following similarities to their respective predicate devices:
· Same indicated use: (see indications statement)
- Same operating principle: "ball-in-socket" cobalt chromium-UHMWPE articular bearing components
- Same materials as predicates: the ApeX -- NK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)
· Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features
· Same shelf life: 5 years from date of manufacture.
· Packaged and sterilized using the same materials and processes: ETO, SAL 10 *.
The only modifications made are:
-
- The addition of a 40 mm size head to the Apex Modular System.
-
- The addition of a 40 mm ID liner to the Apex Modular System.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OMNI Life Science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs Specialist 50 O'Connell Way, Suite 10 E. Taunton, Massachusetts 02718
MAR 2 9 2010
Re: K100555
Trade/Device Name: ApeX-LNK Poly Acetabular Cup Liners and Apex Modular Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: March 23, 2010 Received: March 24, 2010
Dear Ms. Pondicherry:
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.
4
Page 2 - Ms. Radhika Pondicherry
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 (OS) 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,
Barbara Buehum
Mark N. Melk Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K100555
Device Name: ApeX-LNK Poly™ Acetabular Cup Liners,
Apex Modular Head
Indications for Use
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat 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 _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
AND/OR
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qutu for mkm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100555
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