· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

• Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity,

REDAPT Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface.

Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.

Device Description

Smith & Nephew has developed the subject REDAPT Blade Augments as a modification to the previously marketed and cleared REDAPT Augments (S.E. K171073 (S.E. 11/21/2017)). Both the subject REDAPT Blade Augments and the existing REDAPT Augments are porous acetabular augments used to fill bone voids (superior/posterior) where significant bone loss is present and a cup alone cannot fill the void. The subject REDAPT Blade Augments are made of titanium alloy (Ti-6A1-4V) using the same additive manufacturing methods and materials as the predicate REDAPT Augments.

The purpose of this 510(k) submission is to add additional geometry augments to the Smith & Nephew REDAPT family of Total Hip System implants.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the REDAPT Blade Augments, a medical device for hip replacement surgery. The submission claims substantial equivalence to a previously cleared device, the REDAPT Augments (K171073).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

Acceptance Criteria	Reported Device Performance
Fatigue Strength	The subject REDAPT Blade Augment devices met the pre-determined acceptance criteria for each intended output.
Post-Fatigue Lever-out	The subject REDAPT Blade Augment devices met the pre-determined acceptance criteria for each intended output.

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

The document does not explicitly state the sample size used for the test set (e.g., number of specific augments tested). It mentions mechanical verification testing/analysis was conducted. The data provenance is "mechanical verification testing/analysis" performed by Smith & Nephew, Inc. No information regarding country of origin or retrospective/prospective nature is provided for the testing.

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

This information is not provided in the document. The study described is mechanical verification testing, not an assessment requiring expert clinical or imaging review.

4. Adjudication method for the test set

This information is not applicable and therefore not provided, as the study involves mechanical testing against pre-determined acceptance criteria, not expert adjudication of clinical outcomes or imaging.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI in the provided text. This device is a physical hip implant component, and the testing described is mechanical verification.

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

This information is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the mechanical testing was the pre-determined acceptance criteria for fatigue strength and post-fatigue lever-out.

8. The sample size for the training set

This information is not provided and is not applicable to the type of device and testing described. The device is not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable. The device is not an AI/ML algorithm.

Summary

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October 25, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew, Inc. Konrad Wolfmeyer Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K190847

Trade/Device Name: REDAPT Blade Augments Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: September 24, 2019 Received: September 26, 2019

Dear Konrad Wolfmeyer:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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

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Indications for Use

510(k) Number (if known)

Device Name REDAPT Blade Augments

K190847

Indications for Use (Describe)

The REDAPT Augments are indicated for:

REDAPT Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface.

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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K190847

510(k) Summary Smith & Nephew - REDAPT Blade Augment

Submitted by:	Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Date of Summary:	March 29, 2019 Konrad Wolfmeyer Regulatory Affairs Specialist Phone: (901) 399-1367
Name of Device:	REDAPT Blade Augment
Common Name:	Acetabular Bone Augments
Device Classification Name and Reference:	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LPH

Predicate Devices:

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	REDAPT Augments	K171073	11/21/2017

Device Description

The purpose of this 510(k) submission is to add additional geometry augments to the Smith & Nephew REDAPT family of Total Hip System implants.

Indications for Use

The REDAPT Augments are indicated for:

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510(k) Summary Smith & Nephew - REDAPT Blade Augment

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

REDAPT Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface.

Technological Characteristics

Smith & Nephew has evaluated the subject REDAPT Blade Augment devices to demonstrate substantial equivalence to the predicate REDAPT Augment Devices and determined that the subject devices do not represent a new worst case.

Mechanical verification testing/analysis conducted for the subject device, consistent with the predicate device testing, includes:

. Fatigue Strength
. Post-Fatigue Lever-out

The subject REDAPT Blade Augment devices met the pre-determined acceptance criteria for each intended output. Therefore, design verification testing determined that the subject REDAPT Blade Augments are substantially equivalent to the identified predicate devices, cleared in premarket notification K171073.

Substantial Equivalence Information

The subject REDAPT Blade Augments have the same indications for use/intended use as the predicate REDAPT Augments cleared in K171073 (S.E. 11/21/2017). The subject and predicate device Hip Assembly consists of Acetabular Shells and accessory screws, pegs, screw hold covers, Acetabular Augments, Liners, Femoral Heads and Femoral Stems.

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510(k) Summary Smith & Nephew - REDAPT Blade Augment

The subject REDAPT Hip System (Blade Augments) has similar technological . features as the predicate REDAPT Augments.
The subject REDAPT Hip System (Blade Augments) are manufactured from the same material (Titanium Alloy) as the predicate REDAPT Augments.
The subject REDAPT Hip System (Blade Augments) has the same sterilization ● method, utilizes the same porous structure and are manufactured in the same manner as the predicate REDAPT Augments.

The submission is to modify the design of the existing REDAPT Augments to allow for additional geometrical designed augments. Therefore, the technological characteristics of the subject REDAPT Blade Augments Device are the similar to the technological characteristics of the predicate device REDAPT Augments K171073 (S.E. 11/21/2017).

Conclusion

Based on the verification evidence activities provided in this pre-market notification application, the subject REDAPT Blade Augments are substantially equivalent to the legally marketed predicate devices: REDAPT Augments cleared in K171073 (S.E. 11/21/2017).

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.