(21 days)
Not Found
Not Found
No
The description focuses on the material, geometry, and intended use of a hip stem, with no mention of AI or ML capabilities.
Yes
The device is a hip stem intended for cementless fixation in patients requiring hip arthroplasty, which is a medical procedure to treat various joint diseases and deformities. This falls under the definition of a therapeutic device as it is used to alleviate or treat a disease or condition.
No
This device is a hip stem (implant) used for hip arthroplasty, which is a treatment, not a diagnostic procedure. Its purpose is to replace part of the hip joint.
No
The device description explicitly states the device is a titanium alloy hip stem, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Secur-Fit™ Max and Secur-Fit™ Plus Hip Stems are implants designed for surgical insertion into the body (specifically, the femoral canal). They are used to replace a damaged hip joint.
- Intended Use: The intended use clearly states they are for "cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Secur-Fit™ Max and the Secur-Fit™ Plus Max 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; t
- 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 (comma separated list FDA assigned to the subject device)
87 MEH, 87 LZO
Device Description
The subject Secur-Fit™ Max Hip and Secur-Fit™ Plus Max Hip Stems are titanium alloy hip stems. The hip stems have a Commercially Pure Titanium arc deposited circumferential coating with a PureFix™ HA hydroxylapatite surface treatment. The stems are intended for cementless fixation and are available in stem sizes 4-14 and neck lengths ranging from 25mm to 40mm. The stems are available with either a 127° or 132° neck angle. The Secur-Fit" Max Hip stems have a tapered distal geometry. The Secur-Fit" Plus Max Hip Stems have a fluted and slotted distal geometry.
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)
Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength.
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
K051738 P1/2
Special 510(k) Premarket Notification
Line Extension to the SecurFit" and Secur-Fit" Plus Max Hip Stem
JUL 19 2005
510(k) Summary of Safety and Effectiveness
Line Extension to the Secur-Fit™ Max and Secur-Fit™ Plus Max Hip Stem
| Proprietary Name: | Secur-FitTM Max and Secur-FitTM Plus Max Hip Stems |
|---|---|
| Common Name: | Artificial Hip Components |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint, metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prostheses, 21 CFR §888.3353. | |
| Device Product Code: | 87 MEH, Prosthesis, Hip, Semi-Constrained, Uncemented, |
| Metal/Polymer, Non-Porous, Calicum-Phosphate and | |
| 87 LZO: Prosthesis, Hip, Semi-Constrained, | |
| Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | |
| For Information contact: | Karen Ariemma, Senior Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: karen.ariemma@stryker.com | |
| Date Summary Prepared: | June 27, 2005 |
Device Description
The subject Secur-Fit™ Max Hip and Secur-Fit™ Plus Max Hip Stems are titanium alloy hip stems. The hip stems have a Commercially Pure Titanium arc deposited circumferential coating with a PureFix™ HA hydroxylapatite surface treatment. The stems are intended for cementless fixation and are available in stem sizes 4-14 and neck lengths ranging from 25mm to 40mm. The stems are available with either a 127° or 132° neck angle. The Secur-Fit" Max Hip stems have a tapered distal geometry. The Secur-Fit" Plus Max Hip Stems have a fluted and slotted distal geometry.
1
Device Modification
This Secur-Fit" Max and the Secur-Fit" Plus Max Hip Stems were cleared for use with metal and Alumina Ceramic Heads. This submission adds the use of a C-Taper Biolox® Delta Ceramic Femoral Head with the Secur-Fit™ Max and the Secur-Fit™ Plus Max Hip Stems.
Intended Use
The Secur-Fit" Max and the Secur-Fit" Plus Max 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; t
- 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.
Substantial Equivalence
The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical. The material of the subject Secur-Fit" Max and the Secur-Fit™ Plus Max Hip Stems remains unchanged. The subject ceramic femoral heads are fabricated from Zirconia toughened Alumina.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. Mahwah, New Jersey 07430
Re: K051738
K051738
Trade/Device Name: SECUR-Fit™ Max and SECUR-FIT™ PLUS Max 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 Code: LZO, MEH Dated: June 27, 2005 Received: June 28, 2005
Dear Ms. Karen Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manced promoted provice Ameridae, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the enations with the provisions of the Federal Food, Drug, devices that have been recided in accordance while proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require approvide on trols provisions of the Act. The Act. The You may, therefore, thanker the device, basjon to the more in the manual registration, listing of general controls provisions of the free merchibitions 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 (sec above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller in this and to 898. In addition, FDA may be found in the Code of Peacharing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers on bevice complies with other requirements of the Act that FDA has made a decemmanon time your assess. A gencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and issting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), falcing (21 CFR Part 820); go CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regalistin (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your avview of your device of your device to a legally
premarket notification. The FDA finding of substantial end the permits vo premarket notification. The PDA Inding of substantial equivalians 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
rst lead If you desire specific advice for your aconce on our and a gos ande the regulation entitled, the regulation entitled, the contact the Office of Collipiance at (2+0) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by relerence to premarks. Iounted in (c) the Act from the Division of Small other general information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at alled (demanain http://demanain.ht Manufacturers, International and Consumer Processars agov/cdrh/dsma/dsmamain.html
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Signature
Miriam C. Provost, Ph.D Acting 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): ...........
Device Name: SECUR-FIT™ Max and SECUR-FIT™ PLUS Max Hip Stems
Indications For Use:
The Secur-Fit™ Max and Secur-Fit™ Plus Max 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 Secur-Fit™ Max and Secur-Fit™ Plus Max+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.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
Eun A. Oh
eneral, Restorative ical Devices
ve
510(k) No. K0517
Page 1 of of l
(21 CFR 807 Sub