(88 days)
Not Found
Not Found
No
The device description and intended use are for a physical implant (femoral head) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a femoral head intended for use in total hip replacement, which is a therapeutic intervention for various conditions affecting the hip joint.
No
Explanation: The device is a femoral head, which is an implant used in hip replacement surgery. Its purpose is to replace a damaged joint, not to diagnose a condition.
No
The device description clearly states it is a physical component manufactured from Alumina Oxide, designed to articulate with a femoral hip stem. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a component for hip replacement surgery, addressing various conditions affecting the hip joint. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the material and design of a physical implant (femoral head) that articulates with other components in a hip replacement. This is consistent with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies mentioned are analytical and mechanical testing, which are relevant for evaluating the physical properties and performance of an implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace a damaged part of the hip joint.
N/A
Intended Use / Indications for Use
The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:
• The patient should be skeletally mature.
• · The patient's condition should be due to one or more of the following:
- Osteoarthritis.
- Rheumatoid arthritis.
- Tumor conditions involving the upper third of the femur or of the Acetabular.
- Ankylosing spondylitis.
- Psoriatic arthritis.
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
- Non union of femoral neck fracture or avascular necrosis of the femoral head.
- Post-traumatic fracture/dislocation of the hip.
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Acetabular, Hip
Indicated Patient Age Range
The patient should be skeletally mature.
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)
Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head.
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.
Not Found
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.
Not Found
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
§ 888.3353 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
K061564 (P9) of z
510(k) Summary
SUBMITTED FOR:
| Company Name: | Portland Orthopaedics Limited | |
|---|---|---|
| Address: | Unit 3, 44 McCauley St | |
| Matraville, NSW, 2036 Australia | ||
| Telephone: | + 61-2-9666-8444 | |
| Fax: | + 61-2-9666-8544 | |
| SUBMITTED BY: | Elaine Duncan, M.S.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| Address: | Paladin Medical, Inc. | |
| PO Box 560 | ||
| Stillwater, MN 55082, | ||
| United States of America | ||
| Telephone: | +1-715-549-6035 | |
| Fax: | +1-715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | June 1, 2006 | |
| TRADE NAME: | Portland Ceramic (Biolox-Forte) Femoral Head | |
| COMMON NAME: | Ceramic Femoral Head Prosthesis | |
| DEVICE PROCODE & PANEL: | Orthopaedics 87 LZO |
DESCRIPTION of the DEVICE:
REGULATION:
The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.
CFR § 888.3354, Class II
INDICATIONS FOR USE:
The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:
- The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
-
- Osteoarthritis.
-
- Rheumatoid arthritis.
-
1
510(k) Summary-Continued
-
- Tumor conditions involving the upper third of the femur or of the Acetabular.
6061564
- Tumor conditions involving the upper third of the femur or of the Acetabular.
-
- Ankylosing spondylitis.
-
- Psoriatic arthritis.
-
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
-
- Non union of femoral neck fracture or avascular necrosis of the femoral head.
-
- Post-traumatic fracture/dislocation of the hip.
-
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
-
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
-
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
SUBSTANTIAL EQUIVALENCE INFORMATION
The Portland Portland Ceramic (Biolox-Forte) Femoral Head described in this submission is substantially equivalent to ceramic femoral heads manufactured by DePuy, Exactech and Plus, based on similarities of design, intended use, material and manufacturing methods. As demonstrated by the test results and material and the differences in the Portland Ceramic (Biolox-Forte) Femoral Head do not raise any new issues of safety and effectiveness.
SUMMARY of TESTING:
Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2006
Portland Orthopaedics, Ltd. % Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K061564
Trade/Device Name: Portland Ceramic (BIOLOX-Forte) Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 1, 2006 Received: June 5, 2006
Dear Ms. Duncan:
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 - Ms. Elaine Duncan, M.S.M.E., RAC
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.
and the comments of the count
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 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,
Barbara Buchner
for
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): | K061564 |
|---|---|
| Device Name: | Portland Ceramic (Biolox-Forte) Femoral Head |
The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:
• The patient should be skeletally mature.
· The patient's condition should be due to one or more of the following:
-
Osteoarthritis.
-
Rheumatoid arthritis.
-
Tumor conditions involving the upper third of the femur or of the Acetabular.
-
Ankylosing spondylitis.
-
Psoriatic arthritis.
-
Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.
-
Non union of femoral neck fracture or avascular necrosis of the femoral head.
-
Post-traumatic fracture/dislocation of the hip.
-
Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
-
Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
-
Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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
Barbara huckins
Division of General, Restorative, and Neurological Devices
510(k) Number K061564