(72 days)
Not Found
No
The summary describes a revision to a hip stem prosthesis and its associated surgical tools, specifically adding a power-driven option for the awls. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device, described as "implants" for "revision of previously failed hip arthroplasty," clearly aims to alleviate pain, correct deformity, and restore function in patients, which are all characteristics of a therapeutic device.
No
The device description indicates it is an implant (Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis® implants) used for hip arthroplasty, which is a treatment (surgical intervention) rather than a diagnostic procedure.
No
The device description clearly details physical implants (stems) and surgical tools (awls) which are hardware components. The modification involves adding a power-driven option for the awls, further emphasizing the hardware nature of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a hip implant (Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis® implants) used for surgical procedures related to hip joint conditions and revisions. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details the physical characteristics of the implants and a surgical tool (awls) used to prepare the bone for the implant. This aligns with a surgical device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device is a surgical implant and associated surgical tool, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
• Noninflammatory degenerative joint disease (NIDJ), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
• Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, KWZ, JDI
Device Description
The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem crosssection and equally spaced conical anchorage ribs, which run nearly the full length of the stem. The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles. 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm. No changes are being made to the Wagner SL Revision Stem Lateral and the Wagner Cone Prosthesis implants, but one change to the Awls is proposed in this submission: An additional energy type for driving the Wagner -SL Awls and Wagner Cone Awls is introduced: from manually powered use only to manually and power driven use. While manually reaming is still possible the proposed modification enables the use of the awls connected to a powered device to ream the femoral medullary canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Non-Clinical Performance and Conclusions:
The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included:
- Usability Testing
- Similar Device Analysis
Clinical Performance and Conclusions: Clinical data and conclusions were deemed not needed to
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
§ 888.3353 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
Zimmer GmbH Ms. Anne-Kathrin Born Regulatory Affairs Specialist Sulzerallee 8/P.O. Box CH 8404 Winterthur Switzerland
Re: K161192
Trade/Device Name: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System 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: LZO, LPH, KWZ, JDI Dated: June 8, 2016 Received: June 9, 2016
Dear Ms. Anne-Kathrin Born:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161192
Device Name Wagner SL Revision Stem Lateral Wagner Cone Prosthesis® System
Indications for Use (Describe)
• Noninflammatory degenerative joint disease (NIDJ), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of previously failed hip arthroplasty.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anne-Kathrin Born
Specialist, Regulatory Affairs
Telephone: +41 58 85 48 619
Fax: + 41 52 244 86 58 |
| Date: | April 26, 2016 |
| Trade Name: | Wagner Cone Prosthesis® System
Wagner SL Revision Stem Lateral |
| Classification Product Code /
Device Classification Name: | LZO - Prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented
LPH - Prosthesis, hip, semi-constrained,
metal/polymer, porous uncemented
KWZ - Prosthesis, hip, constrained, cemented or
uncemented, metal/polymer
JDI - Prosthesis, hip, semi-constrained,
metal/polymer, cemented |
| Regulation Number / Description: | 21 CFR § 888.3353 - Hip joint
metal/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis
21 CFR § 888.3358 - Hip joint metal/polymer/meta
semi-constrained porous-coated uncemented
prosthesis
21 CFR § 888.3310 – Hip joint metal/polymer
constrained cemented or uncemented prosthesis |
4
21 CFR § 888.3350 - Hip joint metal/polymer semi constrained cemented prosthesis Wagner SL Revision Stem Lateral, manufactured by Predicate Device: Zimmer GmbH, K043356, cleared April 18, 2005 Wagner Cone Prosthesis® System, manufactured by Zimmer GmbH, K113556, cleared February 17, 2012 Device Description: The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem crosssection and equally spaced conical anchorage ribs, which run nearly the full length of the stem. The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles. 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm. No changes are being made to the Wagner SL Revision Stem Lateral and the Wagner Cone Prosthesis implants, but one change to the Awls is proposed in this submission: An additional energy type for driving the Wagner -SL Awls and Wagner Cone Awls is introduced: from manually powered use only to manually and power driven use. While manually reaming is still possible the proposed modification enables the use of the awls connected to a powered device to ream the femoral medullary canal.
5
K161192 Page 3 of 3
| Intended Use: | No changes are made to the intended use of the
Wagner SL Revision Stem Lateral and Wagner Cone
Prosthesis® implants as a result of this modification.
Indications for use include:
- Patient conditions of noninflammatory
degenerative joint disease (NIDJD), e.g.,
avascular necrosis, osteoarthritis; and
inflammatory joint disease (IJD), e.g.,
rheumatoid arthritis. - Patients with failed previous surgery where pain,
deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty.
|
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The Wagner SL Revision Lateral and Wagner Cone
Prosthesis® implants are not modified as compared
to their predicates. Instead, an additional energy type
for driving the Wagner SL Awls and Wagner Cone
Awls is introduced; from manually powered use only
to manually and power driven use. The Wagner SL
Revision Stem Lateral and Wagner Cone Prosthesis
® implants are identical in intended use, materials,
sterility, and performance characteristics to the
predicate devices and remain unchanged. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
The results of non-clinical performance testing and
analyses demonstrate that the devices are safe and
effective and substantially equivalent to the predicate
devices. Performance analyses included:
- Usability Testing
- Similar Device Analysis
Clinical Performance and Conclusions: Clinical data
and conclusions were deemed not needed to
|