(168 days)
Not Found
Not Found
No
The provided 510(k) summary describes a mechanical implant (femoral head) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used in total or partial hip replacement procedures to alleviate severe pain and disability caused by various forms of hip joint damage, thus providing therapy for these conditions.
No
Explanation: This device is indicated for use in hip replacement procedures, which is a treatment, not a diagnostic, procedure. It is used for patients already diagnosed with conditions causing severe pain and disability in the hip joint.
No
The intended use describes a physical implant (femoral head system) used in surgical procedures, which is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in surgical procedures (total or partial hip replacement) to treat structural damage in the hip joint. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The OTI Alumina Ceramic Femoral Head System is a medical device used within the body during surgery to replace a damaged part of the hip joint. This falls under the category of implantable medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-traumatic arthrosis, protrusio acetabuli, slipped Capital Femoral Epiphysis. Use of the prosthesis is also indicated for patients with failed previous fusion, where the hip capsule is incompetent.
Product codes
LZO
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
NOV 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Son Vice President, Technical Affairs Osteoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031
Re: K041443
K041443
Trade Name: OTI Alumina Ceramic Femoral Head System – Line Extension 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: LZO Dated: October 15, 2004 Received: October 18, 2004
Dear Mr. Son:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) presidentially equivalent (for the indications felerenced above and nave use are are are are are are are and and one marketed in interstate for use stated in the encrosule) to regally manated povice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food. Food True commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the cou devices that have been recalismou in acceratively of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, mercrore, market the devices, solirements for annual registration, listing of general controls provisions of the riot 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 If your device is classified (500 a0070) ins. Existing major regulations affecting your device can may be subject to such additional controller is the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casia in gour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oe advised that I Dri 3 ibsuance or our device complies with other requirements of the Act that I DA has made a color coulations administered by other Federal agencies. You must of any it call the Act's requirements ancluding, but not limited to: registration and listing (21 Compry with an the Ace STequirements)01; good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic fordline the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Sam Son
This letter will allow you to begin marketing your device as described in your Section 510(k)
. I eval This letter will allow you to begin haketing your avine equivalence of your device to a legally
premarket notification. The FDA finding of substantial engineerand the premarket notification. The FDA inding of subsalification by 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
rs of the may of the may of 100 - All any descreents the regulation entitle If you desire specific advice for your de vice on on. Also, please not the regulation entitled, the regulation entitled, contact the Office of Compliance at (210) 270 - 1 - 1 - 1 - 1 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 80 Division of Small " Misbranding by reference to picmarket notified on der the Act from the Division of Small
on of Small information on your responsibilities under the Act from wwhat (800) 638 other general information on your responsion.com inst toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-clamemain html Manufacturers, International and Consultion Associated agov/odrh/dsma/dsmamain.html
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Mark A. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510 (k) Number (if known): K041443
Device Name: OTI Alumina Ceramic Femoral Head System – Line Extension
Indications for Use:
OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip OTT Alumina Ceramic Pemoral Tread System in indisability due to structural
replacement procedures for patients suffering severe partmitis arthritis replacement procedures for patients surving sovers thritis, post traumatic arthritis,
damage in the hip joint from rheumatoid arthring of femoral fractures. Use damage in the hip joint from meunatoru artifics, ostooming of femoral fractures. Use
collagen disorders, avascular necrosis, traumatic and wonlassia, protrusio collagen disorders, avascular necrosis, transmith hip dysplasha, protrusion of the prosthesis is also indicated for patients with continues appear of the provious fusion, where acetabuli, silpped Capital Tenford. Oplying 11, 1977, 1977, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999,
Prescription Use ONLY
AND/OR
Over-The-Counter Use N/A (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)
Mark
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041943
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