(35 days)
No
The device description and performance studies focus on the mechanical properties and packaging of the hip prostheses, with no mention of AI or ML capabilities.
Yes
The device is a prosthesis intended to treat degenerative and inflammatory joint diseases, and to revise failed hip arthroplasties which are conditions recognized as medical conditions.
No
The device description and intended use clearly indicate that these are prosthetic implants, specifically for hip arthroplasty and revision procedures, not instruments used to diagnose a medical condition.
No
The device description clearly details physical implants (stems) made of titanium alloy with specific dimensions and features, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a prosthesis for treating joint diseases and failed hip surgeries. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implant (a hip stem) made of titanium alloy with specific design features for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies described relate to packaging integrity and mechanical properties, which are relevant for a surgical implant, not an IVD.
In summary, the device is a surgical implant designed to be placed within the human body, which is the opposite of an in vitro diagnostic device that is used to test samples outside the body.
N/A
Intended Use / Indications for Use
The Wagner Cone Prosthesis is indicated for:
- Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Failed previous surgery where pain, deformity, or dysfunction persists.
- Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Wagner SL Revision Stem Lateral is indicated for:
- 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 cross-section 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.
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: Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products.
Correction of instrument classification from Class I to Class II: Amendment of Design Controls with verification of mechanical integrity and resistance.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key results: any differences do not raise new questions of safety and effectiveness as established with performance testing; and the subject devices are at least as safe and effective as the legally marketed 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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 6, 2019
Zimmer GmbH Anne-Kathrin Born Regulatory Affairs Senior Specialist Sulzerallee 8 Winterthur, 8404 Ch
Re: K191781
Trade/Device Name: Wagner SL Revision Stem Lateral and 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: July 1, 2019 Received: July 2, 2019
Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191781
Device Name Wagner Cone Prosthesis
Indications for Use (Describe)
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
IA 26.06.2019 12:0
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Wagner SL Revision Stem Lateral
Indications for Use (Describe)
· 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K191781
510(K) SUMMARY
Effective date: 02. Feb. 2018
SAP Title: 510(k) Summary
WT-FO 386809 Revision 01 Page 1 of 3
ZIMMER BIOMET Your progress. Our promise."
SAP Document: RA2-418075-E00-01
| Sponsor | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Anne-Kathrin Born
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 619
Fax: + 41 52 244 86 58 |
| Date | June 26, 2019 |
| Trade Name | Wagner Cone Prosthesis® System
Wagner SL Revision Stem Lateral |
| Classification Product Code | LZO, LPH, KWZ, JDI |
| Device Classification Name | Prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented
Prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented
Prosthesis, hip, constrained, cemented or uncemented,
metal/polymer
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/metal semi-
constrained porous-coated uncemented prosthesis
21 CFR § 888.3310 Hip joint metal/polymer constrained
cemented or uncemented prosthesis
21 CFR § 888.3350 Hip joint metal/polymer semi-constrained
cemented prosthesis |
| Predicate Device: | Wagner SL Revision Stem Lateral, manufactured by Zimmer
GmbH, K043356, cleared 04/18/2005
Wagner SL Revision Stem Lateral, manufactured by Zimmer
GmbH, K161192, cleared 07/08/2016
Wagner Cone Prosthesis System, manufactured by Zimmer
GmbH, K113556, cleared 02/17/2012 |
5
K191781
510(K) SUMMARY
Effective date: 02. Feb. 2018
Z ZIMMER BIOMET
Your progress. Our promise.
SAP Document: RA2-418075-E00-01
SAP Title: 510(k) Summary
WT-FO 386809 Revision 01 Page 2 of 3
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 cross-section 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.
Indications for Use:
Wagner Cone Prosthesis
- Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Failed previous surgery where pain, deformity, or dysfunction persists.
- . Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Wagner SL Revision Stem Lateral and
- Revision of previously failed hip arthroplasty .
Comparison to Predicate Device: The intended use of the modified devices, as described in its labeling, has not changed as a result of the modifications proposed in the present submission. Zimmer GmbH proposes modification of the indications for use thereby limiting the indications within those of the previously cleared devices. Two indications for use are proposed to be removed for Wagner SL Revision stems and one indication for Wagner Cone Prosthesis is proposed to be reworded for more clarity. Modification of packaging configuration for the subject implant devices is proposed. The new packaging configuration and the methods to support the package integrity have been previously described in K182048 (Avenir Complete Hip System). The proposed changes do not alter the fundamental scientific technology shared by both the subject devices and predicate devices. Zimmer GmbH is furthermore seeking clearance for certain system-specific
6
Conclusion:
510(K) SUMMARY
SAP Title: 510(k) Summary
WT-FO 386809 Revision 01 Page 3 of 3
ZIMMER BIOMET
Your progress. Our promise.
SAP Document: RA2-418075-E00-01
Class II instruments - these instruments that have previously considered Class I exempt and correction of classification to Class II is proposed within present submission.
Performance Data (Nonclinical and/or Clinical):
Packaging configuration change:
Non-Clinical Performance and Conclusions:
Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products.
Correction of instrument classification from Class I to Class II:
Amendment of Design Controls with verification of mechanical integrity and resistance.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices. Except for the modifications described in this submission the subject devices are identical to the predicate devices, and the
- performance data and analyses demonstrate that: any differences do not raise new questions of safety ●
- and effectiveness as established with performance testing: and
- . the subject devices are at least as safe and effective as the legally marketed predicate devices.