(28 days)
Not Found
No
The 510(k) summary describes a ceramic femoral head for hip replacement, focusing on material composition, dimensions, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a ceramic femoral head intended for use in total hip replacement procedures to treat various joint diseases and fractures, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a ceramic femoral head designed for use as a component in total hip replacement procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical component (ceramic femoral heads) intended for surgical implantation, not a software application.
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 and Intended Use: The provided text clearly describes a surgical implant used in total hip replacement procedures. It is a physical component (femoral head) that is implanted into the body.
- Lack of Diagnostic Function: The device's purpose is to replace a damaged joint component, not to analyze biological samples for diagnostic purposes.
The information provided focuses on the device's material, dimensions, intended surgical use, and performance in mechanical testing, all of which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. 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
LZO
Device Description
The Apex Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrix composite, the femoral heads include diameters ranging from 28mm to 40mm 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
Non-Clinical Test Summary
The following tests were conducted:
- Component testing of BIOLOX forte ball head 32-12/14 L on CoCr test tapers and BIOLOX delta ball heads 28-12/14 L on CoCr test tapers supplied by OMNIIife science.- CeramTec Procedure VA 02 04 4129, ISO-7606-10
- Component testing of BIOLOX delta ball heads 28-12/14 L on titanium test tapers . supplied by OMNIlife science. CeramTec Procedure VA 02 04 4129, ISO-7606-10
- Influence of diameter and neck length on burst strength of BIOLOX forte and BIOLOX . delta ball heads with taper type 12/14- Burst test setup as per ISO-7206-10
- ETO Residuals per ANSI/AAMI/ISO 10993-7.
Clinical Test Summary
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
JUN 2 2 2010
APEX Modular Hip System BIOLOX® delta Femoral Head
May 24, 2010
Radhika Pondicherry OMNI life science, Inc. Submitter Contact 50 O'Connell Way Regulatory Affairs . E. Taunton MA 02718 774-226-1852 (508) 822-6030 (fax)
| Preparation Date | 24 May2010 |
|---|---|
| Device Name | |
| Common Name | Hip joint ceramic, uncemented prosthesis |
| Trade Name | APEX Modular Hip System BIOLOX® delta Femoral Head |
| Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented |
| prosthesis | |
| Regulatory Class | Class II per 21 CFR §888.3353 |
| Product Code | LZO |
| Legally Marketed | |
| Predicate Device(s) | K012918- Apex Modular™ Alumina Femoral Head, November 27, 2001 K073150- ApeX-LNK Poly Acetabular Cup Liners- 36mm Alumina Femoral Heads, February 27, 2008 K100555- ApeX-LNK Poly Acetabular Liners and Apex Modular Head, March 29, 2010 |
| Device Description | The Apex Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrix |
| composite, the femoral heads include diameters ranging from 28mm to 40mm with various | |
| offsets. | |
| Indications for Use | The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the |
| Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This | |
| ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene | |
| acetabular cup or bipolar component. 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 |
Page 1 of 2
1
| | Delta Femoral head
(subject device) | Alumina Femoral head
(K012918, K 073150) | Apex Modular
Head
(K100555) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| INTENDED USE | | | |
| Modular Head,
primary and revision
THA | Yes, cementless | Yes, cementless | Yes, cementless |
| DESIGN | | | |
| Taper design | 12/14 | 12/14 | 12/14 |
| Head Diameters | 28-40mm | 28-36mm | 40mm |
| Head Size & Offsets | 28-+0,+3.5,-3.5 | 28- +0,+3.5,-3.5 | 40mm- +0,+3.5,+7,-
3.5 |
| | 32-+0,+4,+7,-4 | 32- +0,+4,-4 | |
| | 36-+0,+4,+8,-4 | 36-+0,+4,-4 | |
| | 40-+0,+4,+8,-4 | 40mm- not available in
Alumina material | |
| MATERIALS | BIOLOX delta | BIOLOX forte | CoCr Alloy |
| Ceramic Head | 72-75 %Al2O3+,
24-26 % Z2O3 | 99.7% Al2O3 | ASTM-1537 |
| Stem Trunion | Titanium alloy
CoCr alloy | Titanium alloy
CoCr alloy | Titanium alloy
CoCr alloy |
| PACKAGING
AND
STERILIZATION | | | |
| Packaging | Peelable Tyvek®
pouches (1073B
Tyvek®/2.5ml
Mylar®),double
pouched, in a
cardboard box, with
foam inserts, and
tamper resistant
outer labels; the
inner pouch for the
ceramic heads will
be polyethylene
with a peelable
Tyvek®panel. | Peelable Tyvek®
pouches (1073B
Tyvek®/2.5ml
Mylar®), double
pouched, in a cardboard
box, with foam inserts,
and tamper resistant
outer labels; the inner
pouch for the ceramic
heads will be
polyethylene with a
peelable Tyvek®panel. | Paper Board Box,
Double Tyvek inner
pouch |
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| | 10-6 | 10-6 | 10-6 |
Non-Clinical Test Summary
Predicate Device Comparison
The following tests were conducted:
- Component testing of BIOLOX forte ball head 32-12/14 L on CoCr test tapers and BIOLOX . delta ball heads 28-12/14 L on CoCr test tapers supplied by OMNIIife science.- CeramTec Procedure VA 02 04 4129, ISO-7606-10
- Component testing of BIOLOX delta ball heads 28-12/14 L on titanium test tapers . supplied by OMNIlife science. CeramTec Procedure VA 02 04 4129, ISO-7606-10
- Influence of diameter and neck length on burst strength of BIOLOX forte and BIOLOX . delta ball heads with taper type 12/14- Burst test setup as per ISO-7206-10
- ETO Residuals per ANSI/AAMI/ISO 10993-7. .
Clinical Test Summary
No clinical studies were performed.
Conclusions
The - APEX Modular Hip System BIOLOX® delta Femoral Head is substantially equivalent to the predicate devices.
Page 2 of 2
510(k)s-Apex Modular BIOLOX delta Head
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2010
OMNI life science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs 50 O'Connell Way East Taunton, Massachusetts 02718
Re: K101451
Trade/Device Name: APEX Modular Hip System BIOLOX delta Femoral Head Regulation Number: 21 CFR 888.3353
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: LZQ Dated: May 24, 2010 Received: May 25, 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.
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 - Ms. 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/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,
Daniel Keane
( 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): 长 | 0|45 |
Device Name: APEX Modular Hip System BIOLOX delta Femoral Head
The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. 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 (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
Saustin for mxn
(Division Sign-Off)
gical, Orthopedic. and Restorative Devices
510(k) Number K101451