(77 days)
Not Found
Not Found
No
The summary describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a hip stem intended for total hip replacement, which is a structural implant to replace a joint, not a device used for treating a disease or disorder directly through non-invasive or pharmacological means.
No
The device is a hip stem, which is an implant used in total hip replacement, not a tool for diagnosing conditions.
No
The device description clearly states the device is a physical hip stem intended for surgical implantation, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 provided text describes a hip stem, which is an implantable medical device used in total hip replacement surgery. It is a physical component inserted into the patient's body.
- Intended Use: The intended use is for total hip replacement, a surgical procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The intended use of the modified hip stems remains essentially unchanged from that of the predicate hip stems. Like the predicate devices, the subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.
The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).
The indications for use of total hip replacement prostheses include:
- osteoarthritis and avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed, and
- Revision procedures where other treatments including 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
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Neck fatigue testing was performed in accordance with ISO 7206-6.
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
MAY 1 3 2002
Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems
Special 510(k) Summary:
| Proprietary Name: | Super Secur-Fit™ HA Hip Stems and Super Secur-
Fit™ Plus HA Hip Stems |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name : | Artificial Hip Components |
| Classification Name and Reference: | Hip joint, metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis, 21
CFR §888.3353 |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | 87 MEH |
| For Information contact: | Jennifer Daudelin
Howmedica Osteonics Corp.
59 Route 17
Allendale, New Jersey 07401
Phone: (201) 831-5379
Fax: (201) 760-8435 |
Description/Technological Comparison
| Predicate Device Name/Catalog
Series | Subject Modifications | Resulting Subject Device
Name/Catalog # Series |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------|
| Secur-Fit™ HA Hip Stems (6051A
series), 132° neck angle | • Change C-Taper to V40™ Taper
• Trim neck diameter
• Add slot for modular collar | Super Secur-Fit™ HA Hip
Stems (J6051 series) |
| Secur-Fit™ HA Hip Stems (6052A
series), 127° neck angle | • Change C-Taper to V40™ Taper
• Trim neck diameter | Super Secur-Fit™ HA Hip
Stems (J6052 series) |
| Secur-Fit™ Plus HA Hip Stems
(6054A series), 127° neck angle | • Change C-Taper to V40™ Taper
• Trim neck diameter | Super Secur-Fit™ Plus HA
Hip Stems (J6054 series) |
Intended Use
The intended use of the modified hip stems remains essentially unchanged from that of the predicate hip stems. Like the predicate devices, the subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are
Special 510(k)
1
Pge 2 of 2
Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems
Special 510(k)
therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.
Testing Summary
Neck fatigue testing was performed in accordance with ISO 7206-6.
Page 4
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2002
Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401
Re: K020615
Trade/Device Name: Modification to Secur-Fit" HA and Secur-Fit" Plus HA Hip Stems 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: MEH Dated: April 22, 2002 Received: April 23, 2002
Dear Ms. Daudelin:
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 (OS) 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. Jennifer A. Daudelin
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 proficated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Mark N Millan
Witten. Ph.D., M.D. Celia M. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
620615 510(k) Number (if known): _
Device Name: Modification to Secur-Fit™ HA Hip Stems and Secur-FirM Plus HA Hip Stems (Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems)
The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).
Indications:
The indications for use of total hip replacement prostheses include:
- e indications for ass of total inp repartises including osteoarthritis and avascular necrosis, ●
- Rheumatoid arthritis, �
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, and .
- Revision procountes where outler areasing neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use /No (Per 21 CFR 801.109)
(Optional Format 1-2-96)
for Mark n Milhersen
Sion Sign-( Division of General. Restorative and Neurological revices
510(k) Number K020615