The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Description

Subject of this premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively.

Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-6Al-7Nb titanium alloy according to ASTM F1295-05 and ISO 5832-11. The primary stem SL-PLUS is available in 14 size options.

The SL-PLUS lateralized version is an additional 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS Stem, thus giving the surgeon a further option to meet the patient's anatomy. The Caput Collum Diaphysis (CCD) angle is 123° compared to 131° for the standard SL-PLUS Stem. The material and surface characteristics remain unchanged for the lateralized stem as compared to the standard stem.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials and specific performance metrics with acceptance criteria, which is more common for novel or high-risk devices.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, or a study proving it meets such criteria in the way you've outlined. Instead, it focuses on comparing the new device to existing, cleared devices.

Here's a breakdown of what can be extracted and what is not present in relation to your questions:

1. A table of acceptance criteria and the reported device performance:

Not present. This document does not list specific acceptance criteria (e.g., success rates, failure rates, specific measurement tolerances) or quantitative performance data from a dedicated study of the device. The "performance" is implicitly tied to its substantial equivalence to predicate devices that have already demonstrated safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Not present. There is no mention of a "test set" in the context of a study with human subjects, nor any data provenance, as this submission relies on equivalence to existing devices rather than a de novo clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not present. No ground truth establishment using experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not present. This is a hip stem, not an AI diagnostic device. There is no mention of human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable/Not present. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not present. The concept of "ground truth" as it applies to clinical diagnostics or AI performance studies is not relevant here. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not present. There is no mention of a "training set" as this is not a machine learning device or a clinical study that would involve such.

9. How the ground truth for the training set was established:

Not present.

Summary of what the document does provide regarding "performance" and "evaluation":

The "study" proving the device meets criteria is primarily a comparative analysis for substantial equivalence.

Substantial Equivalence Information: The submission states that the "overall designs and the indications for use for the Smith & Nephew SL PLUS Standard and Lateral Femoral Stem are substantially equivalent to the PLUS Orthopedics SL-Plus and SL-Plus Lateralized Stems cleared for market under 510(k) Notifications K001942 and K021178, respectively."
Technological Comparison: The document explicitly states: "The intended use, design, and materials of the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are substantially equivalent to the previously cleared PLUS Orthopedics SL-Plus and SLR-Plus, and the SL-PLUS Lateralized Stems (K001942 & K021178). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This means the "acceptance criteria" are effectively the characteristics and performance of the predicate devices (K001942 and K021178), and the "study" is the demonstration that the new device is sufficiently similar in terms of design, materials, and intended use, and has undergone internal "Design Control Activities" to ensure safety and effectiveness comparable to the predicates. Specific quantitative performance metrics are not typically required for this type of 510(k) submission where substantial equivalence to a well-established device type is being claimed.

Summary

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K072852

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510(K) Summary Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem


SUBMITTER'S NAME:		Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 East Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-6017
CONTACT PERSON:	Nicholas B. Tabrizi
DATE SUMMARY PREPARED:	September 6, 2007
TRADE OR PROPRIETARY DEVICE NAME:	Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem
COMMON OR USUAL NAME:	Total Hip Joint, Femoral Component, Cementless
CLASSIFICATION NAME:	21 CFR888.3353,LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis.
	21 CFR888.3390,KWY	Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis.
	21 CFR888.3360,LWJ	Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis.
DEVICE CLASS:	Class II
PANEL CODE:	Orthopaedics/87/LWJ, LZO, KWY

A. INTENDED USE:

The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

B. DEVICE DESCRIPTION:

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ட். SUBSTANTIAL EQUIVALENCE INFORMATION:

The overall designs and the indications for use for the Smith & Nephew SL PLUS Standard and Lateral Femoral Stem are substantially equivalent to the PLUS Orthopedics SL-Plus and SL-Plus Lateralized Stems cleared for market under 510(k) Notifications K001942 and K021178, respectively.

The Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are similar to the following commercially available devices regarding design features, overall indications, and materials:

Manufacturer	Description	510(K)	Clearance Date
Encore Orthopedics,Inc.	SL-PLUS AND SLR-PLUS	K932481	06/08/94
PLUS Orthopedics.	SL-PLUS AND SLR-PLUS	K001942	07/25/00
PLUS Orthopedics	SL-PLUS Lateralized	K021178	05/14/02

D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, design, and materials of the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are substantially equivalent to the previously cleared PLUS Orthopedics SL-Plus and SLR-Plus, and the SL-PLUS Lateralized Stems (K001942 & K021178). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, bold design, and the text is in a clear, sans-serif font. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2008

Smith & Nephew, Inc. Orthopaedic Division c/o Mr. Nicholas B. Tabrizi Regulatory Affairs Specialist II 1450 East Brooks Road Memphis, Tennessee 38116

Re: K072852

Trade/Device Name: Smith & Nephew SL-PLUS Standard and Lateral Femoral Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented Regulatory Class: Class II Product Code: LZO, KWY, LWY, LWJ Dated: May 30, 2008 Received: June 3, 2008

Dear Mr. Tabrizi:

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 Eederal 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

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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milkman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K072852

Device Name: SL-PLUS Standard and Lateral Hip Stems

Indications for Use:

The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

× · Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not Write Below This Line – Continue on Another Page IF Needed)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

Division of General, Restorative, and Neurological Devices

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Indications.doc

510(k) Number K072852

Regulation Number and Section

§ 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.