(266 days)
No
The document describes surgical instruments and prosthetic components, with no mention of AI or ML capabilities.
Yes
The device, the Instruments for LINK® MEGASYSTEM-C® Family, is intended to aid in the intra-operative implantation of prosthetic components used for knee and hip replacement, and for limb salvage/oncology procedures involving extensive bone loss, trauma, or requiring bone resection and replacement. These applications directly involve treating and managing medical conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as instruments intended to aid in intra-operative implantation of a knee and hip replacement system, and is referred to as "accessory instruments". Its function is to facilitate a surgical procedure, not to diagnose a medical condition.
No
The device description explicitly states it is comprised of "a number of components" and is an "accessory instrument system," indicating it includes physical instruments, not just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the instruments are "intended to aid in intra-operative implantation" of prosthetic components for knee and hip replacement. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as "accessory instrument system" for use with implantable prosthetic components. Instruments used during surgery are not IVDs.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Detecting diseases or conditions through analysis of biological specimens
The device is a surgical instrument system used to facilitate the implantation of prosthetic joints. This falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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;
-
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
§ 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.
0
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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
1
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
2
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;
-
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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) Summary | |
|---|---|
| 510(k) | |
| Submitter: | Link Bio Corp. |
| 69 King Street | |
| Dover, NJ 07801 | |
| Establishment Registration: 3006721341 | |
| Contact | |
| Person: | Terry Powell |
| Regulatory Affairs Program Director | |
| Phone: 973-625-1333, x112 | |
| Fax: 973-625-4445 | |
| E-Mail: terry@linkbio.com | |
| Date Prepared: | January 31, 2019 |
| Trade Name: | Instruments for LINK® MEGASYSTEM-C® Family |
| Common | |
| Name: | Orthopedic Manual Reusable Surgical Instruments (Accessory Instruments to Hip |
| and Knee Implant Systems) | |
| Classification | |
| Name: | Knee joint femorotibial metal/polymer constrained cemented prosthesis; 21 CFR |
| §888.3510, product code KRO |
Hip joint metal/ceramic/polymer semi-constraint cemented or nonporous
uncemented; 21 CFR §888.3353, product code LZO
Hip joint metal/polymer semi-constrained cemented prosthesis; 21 CFR
§888.3350, product code JDI
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; 21 CFR
§888.3360, product code LWJ |
| Classification
and Panel: | Class II, Orthopedic / 87 |
| Predicate
Device: | Accessory Instruments for LINK® MEGASYSTEM-C®, Endo-Model® SL® Rotating
and 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 accessory
instruments previously cleared in K151008 by Waldemar Link GmbH & Co KG. |
| 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). |
| Indications for
Use | 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; |
| | 2) 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 and Non-Rotating Hinge Knee
System additional indications should be noted: - Bone necroses. |
| | 2) 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