(256 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral stem used in hip arthroplasty to treat medical conditions, which fits the definition of a therapeutic device.
No
The device is a femoral stem used in hip replacement surgery to treat conditions like avascular necrosis, osteoarthritis, and rheumatoid arthritis. It is an implant used for treatment, not for diagnosing medical conditions.
No
The device description clearly describes a physical femoral stem, which is a hardware component, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a femoral stem, which is an implantable device used in hip replacement surgery. It is a physical component inserted into the patient's body.
- Intended Use: The intended use is for total or hemi-hip arthroplasty to treat conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; Those patients with failed previous surgery where pain, deformity, or dysfunction persists; Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. This stem is for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWA, KWZ, JDL, LZO, KWY, KWL, LWJ, JDI
Device Description
The Zimmer Porolock MIS Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The curved, uncemented stem and is coated proximally with Titanium Vacuum Plasma Sprayed (Ti-VPS) and rough-blasted distally. The 12/14 femoral stem is available in multiple sizes in order to address different patient morphologies.
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
Prescription Use
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)
Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices.
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.
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
1071723
Summary of Safety and Effectiveness
| Submitter: | Zimmer GmbH
Sulzer Allee 8
Winterthur, Switzerland CH-8404 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, MS, RAC
Senior Associate, Corporate Regulatory Affairs
Telephone: 574-372-4907
Fax: (574) 372-4605 |
| Date: | September 24, 2007 |
| Trade Name: | Zimmer® Porolock" MIS Stem |
| Common Name: | Total Hip Prosthesis |
| Classification Name and Reference: | 1. KWA - Hip joint metal/metal semi-constrained
with uncemented acetabular shell, 21 CFR § 888.
3330
2. JDL - Hip joint metal/metal semi-constrained
with cemented acetabular shell, 21 CFR § 888. 3320
3. LZO - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented
prosthesis, 21 CFR § 888.3353
4. KWY - Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis,
21 CFR § 888.3390
5. KWL - Hip joint femoral (hemi-hip) metallic
cemented or uncemented prosthesis, 21 CFR §
888.3360
6. LWJ - Hip joint femoral (hemi-hip) metallic
cemented or uncemented prosthesis, 21 CFR §
888.3350
7. JDI - Hip joint metal/polymer semi-constrained
cemented prosthesis, 21 CFR § 888.3310
8. KWZ - Hip joint metal/polymer constrained
cemented or uncemented prosthesis, 21 CFR §
888.33 |
1
| Predicate Device: | Zimmer M/L Taper Hip Prosthesis, manufactured
by Zimmer, Inc., K032726, cleared October 22,
2003.
Durom® Acetabular Component and Metasul®
LDH™ Large Diameter Heads, manufactured by
Zimmer GmbH, K053536, cleared March 16, 2006.
Alloclassic® Zweymueller® SL/SLL Femoral Stem,
manufactured by Zimmer GmbH, K030373, cleared
March 6, 2003. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Zimmer Porolock MIS Stem is a modular
femoral stem intended for total or hemi-hip
arthroplasty. The curved, uncemented stem and is
coated proximally with Titanium Vacuum Plasma
Sprayed (Ti-VPS) and rough-blasted distally. The
12/14 femoral stem is available in multiple sizes in
order to address different patient morphologies. |
| Intended Use: | This femoral stem is for total or hemi-hip
arthroplasty and is indicated for the following
conditions:
Patient conditions of noninflammatory degenerative
joint disease (NIDJD), e.g., avascular necrosis,
osteoarthritis, and inflammatory degenerative joint
disease (IJD), e.g., rheumatoid arthritis;
Those patients with failed previous surgery where
pain, deformity, or dysfunction persists;
Revision of previously failed hip arthroplasty.
Total hip replacements may be considered for
younger patients if any unequivocal indication
outweighs the risks associated with the age of the
patient and modified demands regarding activity
and hip joint loading are assured. This includes
severely crippled patients with multiple joint
involvement, for whom an immediate need of hip
mobility leads to an expectation of significant
improvement in the quality of their lives. |
2
Comparison to Predicate Device:
The Zimmer Porolock MIS Stem is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
.
:
: :
Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Zimmer GmbH % Ms. Dalene T. Binkley Senior Associate, Warsaw Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708
Re: K071723 Trade/Device Name: Zimmer® Porolock® MIS Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, KWZ, JDL, LZO, KWY, KWL, LWJ, JDI Dated: March 3, 2008 Received: March 4, 2008
Dear Ms. Binkley:
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.
4
Page 2 - Ms. Dalene Binkley
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K071723 Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Porolock® MIS Stem
Indications for Use:
This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions; Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (I.D), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled pattents with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
This stem is for uncemented use only.
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)
Nil rella fr mxn
Division of Gene I, Restorative. and Neurological Devices
510(k) Number K671723
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