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: 1) Revision for loosened femoral prosthesis components involving extensive bone loss; 2) Surgical intervention for severe trauma: 3) 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: 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 System additional indications should be noted: Bicondylar arthrosis by completely damaged ligaments and muscular instability. 10) 11) Valgus/Varus deformities 20-30°.
Device Story
Manual reusable surgical instruments; designed to assist intra-operative implantation of LINK MEGASYSTEM-C, Endo-Model SL Rotating/Non-Rotating Hinge Knee, and MP Reconstruction Prosthesis systems. Used in orthopedic surgical settings by surgeons. Instruments facilitate bone preparation, component positioning, and implantation. No electronic or software components. Benefit: enables precise surgical execution of complex limb salvage and reconstruction procedures.
Clinical Evidence
No clinical data provided. Performance testing for the implant system was previously established in K151008; no additional performance testing required for these accessory instruments.
Technological Characteristics
Reusable manual surgical instruments. Materials and design are identical to those cleared in K151008. No energy source, connectivity, or software. Sterilization method not specified but consistent with standard reusable orthopedic surgical instrumentation.
Indications for Use
Indicated for limb salvage/oncology procedures including revision for loosened femoral components with extensive bone loss, severe trauma, and oncology cases requiring extensive bone resection/replacement from tibia to hip. Also indicated for knee joint replacement in patients with bone necrosis, bicondylar arthrosis (with damaged ligaments/muscular instability), revision surgery (post-primary total knee or hinged knee replacement), insufficient bone mass, patella flange arthrosis, and valgus/varus deformities up to 30°.
Regulatory Classification
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).
Predicate Devices
Accessory Instruments for LINK® MEGASYSTEM-C®, Endo-Model® SL® Rotating and Non- Rotating Hinge Knee (K151008)
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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 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: 1) Revision for loosened femoral prosthesis components involving extensive bone loss;
2) Surgical intervention for severe trauma:
3) 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:
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 System additional indications should be noted: Bicondylar arthrosis by completely damaged ligaments and muscular instability. 10)
11) 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)<br>Submitter: | Link Bio Corp.<br>69 King Street<br>Dover, NJ 07801<br>Establishment Registration: 3006721341 |
| Contact<br>Person: | Terry Powell<br>Regulatory Affairs Program Director<br>Phone: 973-625-1333, x112<br>Fax: 973-625-4445<br>E-Mail: terry@linkbio.com |
| Date Prepared: | January 31, 2019 |
| Trade Name: | Instruments for LINK® MEGASYSTEM-C® Family |
| Common<br>Name: | Orthopedic Manual Reusable Surgical Instruments (Accessory Instruments to Hip<br>and Knee Implant Systems) |
| Classification<br>Name: | Knee joint femorotibial metal/polymer constrained cemented prosthesis; 21 CFR<br>§888.3510, product code KRO<br><br>Hip joint metal/ceramic/polymer semi-constraint cemented or nonporous<br>uncemented; 21 CFR §888.3353, product code LZO<br><br>Hip joint metal/polymer semi-constrained cemented prosthesis; 21 CFR<br>§888.3350, product code JDI<br><br>Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; 21 CFR<br>§888.3360, product code LWJ |
| Classification<br>and Panel: | Class II, Orthopedic / 87 |
| Predicate<br>Device: | Accessory Instruments for LINK® MEGASYSTEM-C®, Endo-Model® SL® Rotating<br>and Non- Rotating Hinge Knee (K151008), LINK® Endo-Model® Knee System<br>(#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187). |
| Purpose: | Duplicate 510k and line extension filed by Link Bio Corp. for the accessory<br>instruments previously cleared in K151008 by Waldemar Link GmbH & Co KG. |
| Device<br>Description: | The LINK® MEGASYSTEM-C® is comprised of a number of components that are<br>intended to be used in conjunction with each other, or in conjunction with<br>components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee,<br>LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction<br>Prosthesis (#K142187).<br><br>This is a duplicate 510k and line extension in Link Bio Corp.'s name for the<br>accessory instrument system previously cleared in K151008 by Waldemar Link<br>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-<br>Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK®<br>MP® Reconstruction Prosthesis (#K142187). It includes the same instruments as<br>in K151008, and additional accessory instruments (line extension). |
| Indications for<br>Use | The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-<br>operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be<br>integrated with the components of the Endo-Model® SL® Rotating and Non-<br>Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee<br>replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip<br>replacement. The LINK® MEGASYSTEM-C® (K151008), has the following<br>indications: |
| | The LINK® MEGASYSTEM-C® is intended to be used with the components of the<br>Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee<br>System (#K143179) which can be integrated for knee joint replacement and with<br>the MP® Reconstruction Prosthesis (#K142187) for hip replacement. |
| | The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb<br>salvage/Oncology procedures:<br>1) Revision for loosened femoral prosthesis components involving extensive bone<br>loss; |
| | 2) Surgical intervention for severe trauma;<br>3) Oncology cases where extensive resection and replacement of bone is required<br>from tibia to hip area; |
| | The device is to be used with bone cement unless a proximal femur or a modular<br>stem is indicated for use. |
| | For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee<br>System additional indications should be noted:<br>1) Bone necroses. |
| | 2) Bicondylar arthrosis by partly damaged collateral ligaments.<br>3) Revision surgery after primary total knee replacement.<br>4) Revision surgery after rotating or non-rotating hinged knee replacement.<br>5) Revision surgery by insufficient / inadequate bone mass.<br>6) Arthrosis of patella flange.<br>7) Valgus/Varus deformities <10°.<br>8) Valgus/Varus deformities 10-15°.<br>9) Valgus/Varus deformities 15-20°. |
| | For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee System<br>additional indications should be noted:<br>10) Bicondylar arthrosis by completely damaged ligaments and muscular<br>instability. |
| | 11) Valgus/Varus deformities 20-30°. |
| Performance<br>Data: | Extensive performance testing was provided in K151008 for the implant system,<br>but is not required for the accessory instruments. |
| Technological<br>characteristics: | The accessory instruments presented in K151008 are exactly replicated in this<br>duplicate 510k. Additional reusable manual surgical instruments included as a line<br>extension are for the same purpose (to support implantation of the same<br>Waldemar Link GmbH implant systems) as the existing instrument system, with<br>no significant differences in technological features, materials, or intended use. |
| Basis of<br>substantial<br>equivalence: | This 510k is a duplicate in Link Bio Corp.'s name for the accessory instrument<br>system previously cleared in K151008 by its sister company, Waldemar Link GmbH<br>The subject instruments are either identical to those submitted previously in<br>K151008, or represent minor design modifications (line extension) that do not<br>change the intended use of the associated implant system, or represent<br>significant changes to the accessory instruments system. |
# 510(k) Summary
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
