(189 days)
Not Found
No
The document describes a hip stem implant and its intended use and modifications, with no mention of AI or ML technology.
Yes
The device is a hip stem intended for cementless fixation in patients requiring hip arthroplasty to treat various conditions like degenerative joint disease, arthritis, and fractures, which indicates a therapeutic purpose.
No
Explanation: The device is a hip stem intended for cementless fixation in hip arthroplasty, which is a treatment not a diagnostic procedure.
No
The device description clearly states it is a hip stem, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty." This describes a surgical implant used in vivo (within the body) for treatment.
- Device Description: The description talks about "hip stems" and "neck geometry," which are components of a surgical implant.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and .
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
Product codes
87 MEH, 87 LZO
Device Description
The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canals, hip
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)
The testing used to evaluate the subject stems demonstrates substantial length. equivalence of the modified device to the predicate device in regards to neck strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K941366, K951517, 982032, K990203, K020615
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
Traditional 510(k) Summary of Safety and Effectiveness for the MODIFICATION TO SECUR-FIT™ HA AND SECUR-FIT™ PLUS HIP STEMS
| Proprietary Name: | Secur-Fit™ HA and Secur-Fit™ Plus Hip |
|---|---|
| Stems | |
| Common Name: | Artificial Hip Components |
| Classification Name and Reference | Hip joint, metal/ceramic/polymer semi- |
| constrained cemented or nonporous | |
| uncemented prostheses, | |
| 21 CFR §888.3353 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MEH, 87 LZO |
| For Information contact: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| Phone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| E-Mail: karen.ariemma@stryker.com |
Date Summary Prepared:
November 4, 2004
Device Description
The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.
Intended Use:
The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
Indications for Use
The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and .
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
1
Substantial Equivalence:
The features of the modified stems are substantially equivalent to the corresponding features of the predicate Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamlined neck geometry and the modified C-Taper trunnion The testing used to evaluate the subject stems demonstrates substantial length. equivalence of the modified device to the predicate device in regards to neck strength. In addition, the intended use, material, manufacturing methods, packaging, package insert, and sterilization of the modified and unmodified stems are identical.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three figures or lines above a wavy base, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. New Jersey 07430
Re: K041170
Trade/Device Name: Modification to Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, MEH Dated: October 15, 2004 Received: October 21, 2004
Dear Ms. Ariemma:
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
3
Page 2 - Karen Ariemma
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. 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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known): __K041170
Device Name: Modification to SECUR-FIT™ HA and SECUR-FIT™ PLUS Hip Stems
Indications For Use:
The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
- . Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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 K041170