(63 days)
No
The document describes a hip replacement system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical properties and design of the implants.
Yes
The device, the Apex Hip System, is intended for total hip replacement to treat various conditions like degenerative joint disease and rheumatoid arthritis, which are therapeutic interventions.
No
This device is described as an Apex Hip System, intended for total hip replacement, and includes descriptions of hip stems, acetabular cups, and liners. These are surgical implants, not diagnostic tools. The "Intended Use" section explicitly states its use in replacing joints for various conditions, which is a treatment, not a diagnosis.
No
The device description and performance studies clearly indicate this is a physical hip implant system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a hip replacement system, which is an implantable medical device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use clearly states "primary or revision total hip replacement," which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems 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, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses 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
Device Description
Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, 32, 36, 40mm Apex Modular heads.
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
Non-Clinical Test Summary
The following tests were conducted:
- ROM analysis per ISO-21535-2007 .
- . Extreme artificial aging per ASTM F2003-02
- . Push-out & Lever-out Test
All samples tested met the acceptance criteria.
Clinical Test Summary Conclusions
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K031110, K062489, K073150, K100555
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
K101976 (pg 1/2)
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ੋਂ ਨੂੰ
Appendix C
SEP 1 ,4 2010
510(k) Summary
| Interface Acetabular System, Acetabular Insert | 17 Aug, 2010 | |||
|---|---|---|---|---|
| Submitter | OMNI life science, Inc. | |||
| 50 O'Connell Way | ||||
| E. Taunton MA 02718 | Contact | Radhika Pondicherry | ||
| Regulatory Affairs | ||||
| 774-226-1852 | ||||
| (508) 822-6030 (fax) | ||||
| Preparation Date | 17 Aug 2010 | Device Name | Interface Acetabular System, Acetabular Insert | |
| Trade Name | Interface Acetabular System, Acetabular Insert | |||
| Common/Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | |||
| uncemented prosthesis | ||||
| Regulatory Class | Class II per 21 CFR §888.3358 | |||
| Product Code | LPH | |||
| Legally Marketed | ||||
| Predicate | ||||
| Device(s) | K031110 Apex Modular Acetabular Cup, May 22, 2003 K062489 Apex HCLA Acetabular Cup Liners August 15, 2007 K073150 ApeX-LNK Poly™ Acetabular Cup Liners K100555 ApeX-LNK Poly™ Acetabular Cup Liners, March 29, 2010 | |||
| Device | ||||
| Description | Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, | |||
| 32, 36, 40mm Apex Modular heads. | ||||
| Indications for | ||||
| Use | The Apex Hip System is intended for primary or revision total hip replacement. | |||
| The femoral hip stems and acetabular cups 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, Apex K2 mid length or Apex K1 | ||||
| Hip in total hip replacement procedures. The acetabular cup inserts are intended | ||||
| to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. | ||||
| These prostheses 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 |
.
·
1
Predicate Device Comparison
| | Acetabular
Insert
(subject device) | Apex Hip System
Standard
UHMWPE
(K031110) | Apex Hip System
Crosslinked
UHMWPE
(K062489,
K073150, K100555) |
|-------------------------------|------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------|
| DESIGN | | | |
| Insert engagement | 19° taper and PE
locking ring | 19° taper and PE
locking ring | 19° taper and PE
locking ring |
| Inserts- Hooded/
Neutral | Neutral
10° hooded | Neutral
15° hooded | Neutral
10° hooded |
| Insert offset | +4mm | None | None |
| Insert Thickness
(minimum) | Worst case size
has a minimum
thickness of
8.6mm. | Minimum
thickness of 6mm
at the load
bearing region. | Minimum thickness
of 6mm at the load
bearing region. |
| Head Diameters | 28, 32, 36 and
40mm | 28 and 32, mm | 28, 32, 36 and
40mm |
| MATERIALS | | | |
| Cross-linked UHMWPE | Yes | No | Yes |
| Standard UHMWP | Yes | Yes | No |
| Standards | ASTM F648 | ASTM F648 | ASTM F648 |
Non-Clinical Test Summary
The following tests were conducted:
- ROM analysis per ISO-21535-2007 .
- . Extreme artificial aging per ASTM F2003-02
- . Push-out & Lever-out Test
All samples tested met the acceptance criteria.
Clinical Test Summary Conclusions
No clinical studies were performed.
The Interface Acetabular System, Acetabular Insert is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Omni Life Science, Inc. % Radhika Pondicherry 50 O'Connell Way East Taunton, MA 02718
SEP 1 4 2010
Re: K101976
Trade/Device Name: Interface Acetabular System, Acetabular Insert 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 Dated: August 17, 2010 Received: August 19, 2010
Dear Mr. 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. Ilsting 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
3
Page 2 - Mr. Radhika Pondicherry
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/ucm11.5809.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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Peter Hamer, D.D.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K101976 (pg 1/1)
Indications for Use
510(k) Number:
Device Name: Interface Acetabular System, Acetabular Insert, +4 offset
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems 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, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a neal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses 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 (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)
Page 1 of 1
Santur
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(Devision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K,01976