The Instruments for LINK® MEGASYSTEM-C® Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:

The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.

The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:

Revision for loosened femoral prosthesis components involving extensive bone loss;
Surgical intervention for severe trauma;
Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;

The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.

For the use of the LINK® Endo-Model® SL® Rotating Hinge Knee System additional indications should be noted:

Bone necroses.
Bicondylar arthrosis by partly damaged collateral ligaments.
Revision surgery after primary total knee replacement.
Revision surgery after rotating or non-rotating hinged knee replacement.
Revision surgery by insufficient / inadequate bone mass.
Arthrosis of patella flange.
Valgus/Varus deformities <10°.
Valgus/Varus deformities 10-15°.
Valgus/Varus deformities 15-20°.

For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee System additional indications should be noted:
10) Bicondylar arthrosis by completely damaged ligaments and muscular instability.
11) Valgus/Varus deformities 20-30°.

Device Description

The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187).

This is a duplicate 510k and line extension in Link Bio Corp.'s name for the accessory instrument system previously cleared in K151008 by Waldemar Link GmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). It includes the same instruments as in K151008, and additional accessory instruments (line extension).

AI/ML Overview

The provided text describes a 510(k) premarket notification for surgical instruments used in knee and hip replacement (Trade/Device Name: Instruments for LINK® MEGASYSTEM-C® Family). This submission is a duplicate 510(k) and line extension for accessory instruments previously cleared under K151008.

Based on the provided document, the device in question is a set of manual reusable surgical instruments, not an AI/ML-driven device or a device that generates diagnostic data that would typically have acceptance criteria related to sensitivity, specificity, or similar performance metrics. The document explicitly states:

"Extensive performance testing was provided in K151008 for the implant system, but is not required for the accessory instruments."

And regarding technological characteristics:

"The accessory instruments presented in K151008 are exactly replicated in this duplicate 510k. Additional reusable manual surgical instruments included as a line extension are for the same purpose (to support implantation of the same Waldemar Link GmbH implant systems) as the existing instrument system, with no significant differences in technological features, materials, or intended use."

Therefore, the following information cannot be extracted from this document as it pertains to AI/ML or data-driven diagnostic devices, which this product is not:

Acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics)
Sample size for the test set and data provenance
Number of experts and their qualifications for ground truth establishment
Adjudication method
MRMC comparative effectiveness study results
Standalone performance
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for the training set
How ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a predicate device (K151008) based on the instruments being identical or having minor design modifications that do not change their intended use or function. No "study" in the sense of a clinical trial or performance evaluation against specific diagnostic metrics is mentioned for these instruments.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.

October 25, 2019

Link Bio Corp. Terry Powell Regulatory Affairs Program Director 101 Roundhill Drive Rockaway, New Jersey 07866

Re: K190181

Trade/Device Name: Instruments for LINK® MEGASYSTEM-C® Family Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, LWJ, LZO, JDI Dated: September 30, 2019 Received: October 1, 2019

Dear Terry Powell:

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 Ting Song, Ph.D. 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) K190181

Device Name

Instruments for LINK® MegaSystem-C® Family

Indications for Use (Describe)

The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:

The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures: 1) Revision for loosened femoral prosthesis components involving extensive bone loss;

Surgical intervention for severe trauma:
Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;

The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.

For the use of the LINK® Endo-Model® SL® Rotating Hinge Knee System additional indications should be noted:

Bone necroses.
Bicondylar arthrosis by partly damaged collateral ligaments.
Revision surgery after primary total knee replacement.
Revision surgery after rotating or non-rotating hinged knee replacement.
Revision surgery by insufficient / inadequate bone mass.
Arthrosis of patella flange.
Valgus/Varus deformities <10°.
Valgus/Varus deformities 10-15°.
Valgus/Varus deformities 15-20°.

For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee System additional indications should be noted: Bicondylar arthrosis by completely damaged ligaments and muscular instability. 10)

Valgus/Varus deformities 20-30°.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary
510(k)Submitter:	Link Bio Corp.69 King StreetDover, NJ 07801Establishment Registration: 3006721341
ContactPerson:	Terry PowellRegulatory Affairs Program DirectorPhone: 973-625-1333, x112Fax: 973-625-4445E-Mail: terry@linkbio.com
Date Prepared:	January 31, 2019
Trade Name:	Instruments for LINK® MEGASYSTEM-C® Family
CommonName:	Orthopedic Manual Reusable Surgical Instruments (Accessory Instruments to Hipand Knee Implant Systems)
ClassificationName:	Knee joint femorotibial metal/polymer constrained cemented prosthesis; 21 CFR§888.3510, product code KROHip joint metal/ceramic/polymer semi-constraint cemented or nonporousuncemented; 21 CFR §888.3353, product code LZOHip joint metal/polymer semi-constrained cemented prosthesis; 21 CFR§888.3350, product code JDIHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; 21 CFR§888.3360, product code LWJ
Classificationand Panel:	Class II, Orthopedic / 87
PredicateDevice:	Accessory Instruments for LINK® MEGASYSTEM-C®, Endo-Model® SL® Rotatingand Non- Rotating Hinge Knee (K151008), LINK® Endo-Model® Knee System(#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187).
Purpose:	Duplicate 510k and line extension filed by Link Bio Corp. for the accessoryinstruments previously cleared in K151008 by Waldemar Link GmbH & Co KG.
DeviceDescription:	The LINK® MEGASYSTEM-C® is comprised of a number of components that areintended to be used in conjunction with each other, or in conjunction withcomponents of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee,LINK® Endo-Model® Knee System (#K143179) and LINK® MP® ReconstructionProsthesis (#K142187).This is a duplicate 510k and line extension in Link Bio Corp.'s name for theaccessory instrument system previously cleared in K151008 by Waldemar LinkGmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and in
	conjunction with components of LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK®MP® Reconstruction Prosthesis (#K142187). It includes the same instruments asin K151008, and additional accessory instruments (line extension).
Indications forUse	The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can beintegrated with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for kneereplacement, and with the MP® Reconstruction Prosthesis (#K142187) for hipreplacement. The LINK® MEGASYSTEM-C® (K151008), has the followingindications:
	The LINK® MEGASYSTEM-C® is intended to be used with the components of theEndo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® KneeSystem (#K143179) which can be integrated for knee joint replacement and withthe MP® Reconstruction Prosthesis (#K142187) for hip replacement.
	The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limbsalvage/Oncology procedures:1) Revision for loosened femoral prosthesis components involving extensive boneloss;
	2) Surgical intervention for severe trauma;3) Oncology cases where extensive resection and replacement of bone is requiredfrom tibia to hip area;
	The device is to be used with bone cement unless a proximal femur or a modularstem is indicated for use.
	For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge KneeSystem additional indications should be noted:1) Bone necroses.
	2) Bicondylar arthrosis by partly damaged collateral ligaments.3) Revision surgery after primary total knee replacement.4) Revision surgery after rotating or non-rotating hinged knee replacement.5) Revision surgery by insufficient / inadequate bone mass.6) Arthrosis of patella flange.7) Valgus/Varus deformities <10°.8) Valgus/Varus deformities 10-15°.9) Valgus/Varus deformities 15-20°.
	For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee Systemadditional indications should be noted:10) Bicondylar arthrosis by completely damaged ligaments and muscularinstability.
	11) Valgus/Varus deformities 20-30°.
PerformanceData:	Extensive performance testing was provided in K151008 for the implant system,but is not required for the accessory instruments.
Technologicalcharacteristics:	The accessory instruments presented in K151008 are exactly replicated in thisduplicate 510k. Additional reusable manual surgical instruments included as a lineextension are for the same purpose (to support implantation of the sameWaldemar Link GmbH implant systems) as the existing instrument system, withno significant differences in technological features, materials, or intended use.
Basis ofsubstantialequivalence:	This 510k is a duplicate in Link Bio Corp.'s name for the accessory instrumentsystem previously cleared in K151008 by its sister company, Waldemar Link GmbHThe subject instruments are either identical to those submitted previously inK151008, or represent minor design modifications (line extension) that do notchange the intended use of the associated implant system, or representsignificant changes to the accessory instruments system.

510(k) Summary

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Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.