K Number
K043356
Device Name
WAGNER SL REVISION STEM LATERAL
Date Cleared
2005-04-18

(133 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications 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.
Device Description
Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems 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, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted. To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength. In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.
More Information

Not Found

No
The summary describes a mechanical implant (femoral stem) and its design modifications. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

Yes.

The device is intended for prosthetic replacement of the proximal femur in total hip arthroplasty to treat patient conditions such as noninflammatory degenerative joint disease and inflammatory joint disease, indicating its use in managing and treating medical conditions.

No

The device is a prosthetic implant (revision stem) for surgical replacement of the proximal femur, not a tool used to diagnose medical conditions. The "Specific diagnostic indications" section refers to conditions for which the device may be used, not diagnostic capabilities of the device itself.

No

The device description clearly states it is a physical implant made from forged titanium alloy, intended for surgical implantation in the proximal femur. It describes physical characteristics like length, taper, cross-section, ribs, and a threaded coupling.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for prosthetic replacement of the proximal femur in total hip arthroplasty. This is a surgical procedure involving the implantation of a medical device into the body.
  • Device Description: The device is a physical implant (a revision stem) made of titanium alloy. It is designed to be surgically implanted.
  • Lack of Diagnostic Function: The description does not mention any function related to diagnosing a disease or condition. It is a therapeutic device used to treat existing conditions (degenerative joint disease, inflammatory joint disease, failed previous surgery, failed hip arthroplasty).
  • No Mention of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. This device is implanted inside the body.

Therefore, the Wagner SL Revision Stem Lateral is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur and acetabulum in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications 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.

Product codes (comma separated list FDA assigned to the subject device)

87 LZO

Device Description

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (145mm, 175mm, 205mm). The neck design of both stems 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, as do a previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib bending moment and lateral of so that the greatest bending moment would not be structure was rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use m' addition, a throuded couping was shortened and the stem neck with the new impacterese the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal femur and acetabulum

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)

Not Found

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.

K953689

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

K04 3356 (pg 1 of 2)

APR 1 8 2005

510(k) SUMMARY

Zimmer Austin, Inc. SPONSOR NAME: 9900 Spectrum Drive Austin, TX 78717

  • Zimmer GmbH MANUFACTURER: Sulzer Allee 8 Winterthur, 8404 Switzerland
  • Audrey Swearingen CONTACT: Phone: (512) 432-9255 audrey.swearingen@zimmer.com E-Mail:

Wagner SL Revision Stem Lateral TRADE NAME:

Hip joint metal/ceramic/polymer semi-constrained cemented COMMON NAME: or nonporous uncemented prosthesis

Hip joint metal/ceramic/polymer semi-constrained cemented CLASSIFICATION: or nonporous uncemented prostheses (Product Code 87 LZO) are Class II per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel.

PREDICATE DEVICE: Wagner SL Revision Stem (K953689)

DEVICE DESCRIPTION:

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three ിശേഷം വി 6 managan 6 managan (205mm). The neck design of both stems 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, as do oducily open a previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was To acrieve the fateralization of the lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib bending momonto and later of so that the greatest bending moment would not be structure was rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use m' addition, a throuded couping was shortened and the stem neck with the new impacterese the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

1

K043356 (pg. 2 of 2)

INTENDED USE:

INTENDED OSE.
The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the The Wagner OL Tevilion of the Eater Eater hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

  • ിരക്കം Openino diagnootio immetory degenerative joint disease (NIDJD), e.g., � r attent conditions of neninthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
  • medifiation artimas.
    Patients with failed previous surgery where pain, deformity, or dysfunction persists. �
  • Revision of previously failed hip arthroplasty. �

BASIS OF SUBSTANTIAL EQUIVALENCE:

BASIS OF OODOTARTIAly equivalent in terms of fundamental design, The device, as modified, to casations for use and intended use to the previously cleared, currently marketed Wagner SL Revision Stem.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines or strokes, possibly representing a stylized human figure or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2005

Ms. Audry Swearingen Regulatory Affairs Manager Zimmer Austin, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K043356

Trade/Device Name: Wagner SL Revision Stem Lateral 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 Dated: March 17, 2005

Received: March 21, 2005

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQtr) premised is substantially equivalent (for the indications felerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally the Medical Device Amendments, or to conninetee prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been reclassified in accerative while in a premarket approval application (PMA). and Cosment Act (Act) that do not require appen o the general controls provisions of the Act. The You may, merelore, market the act include requirements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (36c doove) inc. Existing major regulations affecting your device all in a liting EDA it may be subject to such additional conditions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feasta, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not t Please be advised that I DA 3 issuales of a cosenia
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delemination administered by other Federal agencies. You must or any receral statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, mercessed ing practice requirements as set and CFR Part 807), labeling (21 CFRT art 807), good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 11 applicable, 1950 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 – Ms. Audry Swearingen

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the p premarket notification. The PDATIManig of basisting of 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
s and the may and and and and and the color station and the reculation cont if you desire specific advice for your active of your and success not the regulation entitled, the open abtain contact the Office of Collipitalice at (240) 270 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 ct first from the Division of Small "Misbranding by relerence to premarks noutheanon" (2) 300 the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or 100-Manufacturers, International and Consumer Prosisanet Prosisanter Propport/index.html.

Sincerely yours,

Stupt Plurle

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): 15043356

Wagner SL Revision Stem Lateral Device Name:

Indications for Use:

The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal Price wagner BB reviewing total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

  • Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular � necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., theumatoid arthritis.
  • Patients with failed previous surgery where pain, deformity, or dysfunction persists. �
  • Revision of previously failed hip arthroplasty. �

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rlurdu

(Division Sign-Division of General, From Stive. and Neurological Devices

510(k) Number K043356

Page of __ of_

(Posted November 13, 2003)