(116 days)
Not Found
No
The device description focuses on the materials and mechanical function of surgical implants and instruments for ACL reconstruction. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The devices are implants used for fixation of grafts during ligament reconstruction, which directly treat a medical condition.
No
This device is a surgical implant designed for fixation of grafts during cruciate ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical implants (absorbable pins, sheaths, and screws) and reusable surgical instruments made of stainless steel. There is no mention of software as a component of the device.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The descriptions clearly state that these devices are implants (pins, sheaths, screws) used for the fixation of grafts during surgical procedures (ACL reconstruction). They are physically implanted into the body to hold tissue in place.
- Lack of Specimen Analysis: There is no mention of these devices being used to analyze any biological specimens outside of the body.
Therefore, these devices fall under the category of surgical implants or orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.
The RigidFix Biocryl Fcmoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The BioIntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts gr bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HTY, HWC
Device Description
RigidFix Biocryl Cross Pin Kits
The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are used for the fixation of bone-tendon-bone grafts to the femur and the tibia in Anterior Cruciate Ligament (ACL) reconstruction. A total of four RigidFix Biocryl 2.7 mm BTB Cross Pins are used to complete the reconstruction: two on the femur and two on the tibia.
The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used to complete the repair.
The proposed RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/ 85%PLA) material. The proposed RigidFix biocryl Tibial 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are used to complete the repair.
Each RigidFix Biocryl Cross Pin Kit is provided sterile and is for single patient use only.
Except for the Interlocking Trocar and Sleeve assemblies that are packaged in the RigidFix kits with the RigidFix Biocryl pins, other reusable instrumentation is offered separately to assist in the placement of the RigidFix Biocryl pins. The instrumentation consists of Tibial Guide Frame, Tibial Rods, Long Stepped Trocar, Trocar Trial, Guide Block Head Thumb Screw, Probe, Short Stepped Trocar, Tibial Pin Insertion Rod and Femora/Tibial Rod Thumb Screw. These devices are all stainless steel, non-sterile, reusable devices. In accordance to CFR §888.4540, these are Class I devices and, therefore, are exempt from 510(k) premarketing notification procedures. Validated cleaning and sterilization instructions are provided for those instruments.
BioIntrafix Tibial Tapered Sheaths and Screws
The DePuy Mitek BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are absorbable implants made from a composite of absorbable Polylactic Acid (PLA) Polymer and Tricalcium Phosphate (TCP). They are used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are supplied sterile ready to use. The tie tensioner is a non-sterile, reusable instrument used to apply and measure tension on the graft.
Biocryl Interference Screws
The DePuy Mitek Biocryl Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly Lactic Acid.(PLA) polymer and Tricalcium Phosphate (TCP). The Biocryl Interference Screw is packaged one per pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of performance and safety testing have been submitted in the predicate 510(k)'s (i.e. K090669 for RigidFix Biocryl Cross Pin Kits, K032167 for BioIntrafix Tibial Sheaths and Screws, and K013572 for Biocryl Interference Screws) and have demonstrated that the devices are suitable for their intended use.
Based on the identical indications for use and technological characteristics as compared to the predicate devices, the proposed RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Sheaths and Screws, and Biocryl Interference Screws have shown to be substantially equivalent to their respective predicate devices under the Federal Food, Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SECTION 2 – 510(k) SUMMARY
Raynham, MA 02767
DePuy Mitek, Inc.
Regulatory Affairs Specialist
a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767, USA Telephone: 508-977-3966
Zheng Liu
RigidFix BiocryI Cross Pin Kits BioIntrafix Tibial Tapered Sheaths and Screws Biocryl Interference Screws
AUG 0 7 2009
DePuy Mitek Submitter's Name and a Johnson & Johnson company Address: 325 Paramount Drive
Contact Person
Name of Medical Device
Facsimile: 508-977-6955 e-mail: zliu8@its.jnj.com Classification Name: Single/multiple component metallic bone fixation appliances and accessories Common/Usual Name: Bone Anchor RigidFix Biocryl Cross Pin Kits Proprietary Name: BioIntrafix Tibial Tapered Sheaths and Screws Biocryl Interference Screws
Substantial Equivalence
and Restorative Deyice
BioIntrafix Tibial Tapered Sheaths and Screws are substantially equivalent to: (Division Sign-Off) Division of Surgical, Orthopedic,
트
- K032167 BioIntrafix Tibial Tapered Sheaths and Screws (October 이 15, 2003).
RigidFix Biocryl Cross Pin Kits are substantially equivalent to:
K090669 RigidFix Biocryl Cross Pin Kits (April 03, 2009).
Biocryl Interference Screws are substantially equivalent to:
510(k) Number
- K013572 Biocryl Interference Screws (March 14, 2002).
Premarket Notification: Traditional
RigidFix Biocryl Cross Pin Kits, Biocryl Interference Screws, BioIntrafix Tibial Tapered Sheaths and Screws
1
| Device Classification | These devices carry an FDA product code MAI, and subsequent code
HTY, and is classified as single/multiple component metallic bone
fixation appliances and accessories under 21 CFR 888.3030. |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | RigidFix Biocryl Cross Pin Kits |
| | The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are
absorbable implants manufactured from "Biocryl" (15% ß-TCP/
85%PLA) material. The proposed RigidFix Biocryl 2.7 mm BTB Cross
Pins are used for the fixation of bone-tendon-bone grafts to the femur
and the tibia in Anterior Cruciate Ligament (ACL) reconstruction. A
total of four RigidFix Biocryl 2.7 mm BTB Cross Pins are used to
complete the reconstruction: two on the femur and two on the tibia. |
| | The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are
absorbable implants manufactured from "Biocryl" (15% ß-TCP/
85%PLA) material. The proposed RigidFix Biocryl Femoral 3.3 mm
ST Cross Pins are used for the fixation of soft tissue (semitendinosus
and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix
Biocryl Femoral 3.3 mm ST Cross Pins are used to complete the repair. |
| | The proposed RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are
absorbable implants manufactured from "Biocryl" (15% ß-TCP/
85%PLA) material. The proposed RigidFix biocryl Tibial 3.3 mm ST
Cross Pins are used for the fixation of soft tissue (semitendinosus and
gracillis) grafts to the femur in ACL reconstruction. Two RigidFix
Biocryl Tibial 3.3 mm ST Cross Pins are used to complete the repair. |
| (Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number | Each RigidFix Biocryl Cross Pin Kit is provided sterile and is for single
patient use only. |
| | Except for the Interlocking Trocar and Sleeve assemblies that are
packaged in the RigidFix kits with the RigidFix Biocryl pins, other
reusable instrumentation is offered separately to assist in the placement
of the RigidFix Biocryl pins. The instrumentation consists of Tibial
Guide Frame, Tibial Rods, Long Stepped Trocar, Trocar Trial, Guide
Block Head Thumb Screw, Probe, Short Stepped Trocar, Tibial Pin
Insertion Rod and Femora/Tibial Rod Thumb Screw. These devices are
all stainless steel, non-sterile, reusable devices. In accordance to CFR
§888.4540, these are Class I devices and, therefore, are exempt from
510(k) premarketing notification procedures. Validated cleaning and
sterilization instructions are provided for those instruments. |
| | BioIntrafix Tibial Tapered Sheaths and Screws |
The DePuy Mitek BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are absorbable implants made from a composite of absorbable Polylactic Acid (PLA) Polymer and Tricalcium Phosphate (TCP). They are used to secure soft tissue grafts to the bone during
Premarket Notification: Traditional RigidFix Biocryl Cross Pin Kits, Biocryl Interference Screws, BioIntrafix Tibial Tapered Sheaths and Screws
2
cruciate ligament reconstruction. The BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are supplied sterile ready to use. The tie tensioner is a non-sterile, reusable instrument used to apply and measure tension on the graft.
Biocryl Interference Screws
The DePuy Mitek Biocryl Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly Lactic Acid.(PLA) polymer and Tricalcium Phosphate (TCP). The Biocryl Interference Screw is packaged one per pouch.
RigidFix Biocryl Cross Pin Kits
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended for femoral and/or tibial fixation of autograft or allograft ACL Bonetendon-bone grafts.
The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
BioIntrafix Tibial Tapered Sheaths and Screws
The BioIntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
Biocryl Interference Screws
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
This premarket notification is submitted to have the protocol of the 36month stability study reviewed to support a 3-year shelf life claim on the proposed products (i.e. RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, and Biocryl Interference Screws). No other changes have been made to the predicate devices.
The proposed products have the same indication statements and the same technological characteristics (e.g., design, materials, etc.) as that of the respective predicate products. In addition, the descriptive characteristics are precise enough to establish substantial equivalence
Premarket Notification: Traditional
Safety and Performance
RigidFix Biocryl Cross Pin Kits, Biocryl Interference Screws, BioIntrafix Tibial Tapered Sheaths and Screws
Indications for Use
3
between the proposed products and their respective predicates. Therefore, additional safety and performance testing on the proposed products are not necessary.
Results of performance and safety testing have been submitted in the predicate 510(k)'s (i.e. K090669 for RigidFix Biocryl Cross Pin Kits, K032167 for BioIntrafix Tibial Sheaths and Screws, and K013572 for Biocryl Interference Screws) and have demonstrated that the devices are suitable for their intended use.
Based on the identical indications for use and technological characteristics as compared to the predicate devices, the proposed RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Sheaths and Screws, and Biocryl Interference Screws have shown to be substantially equivalent to their respective predicate devices under the Federal Food, Drug and Cosmetic Act.
DK
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number 1109/04/
Premarket Notification: Traditional RigidFix Biocryl Cross Pin Kits, Biocryl Interference Screws, BioIntrafix Tibial Tapered Sheaths and Screws
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes, positioned above a wavy, ribbon-like element. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek A Johnson & Johnson Company % Ms. Zheng Liu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
AUG 0 7 2009
Re: K091041
Trade/Device Name: RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, Biocryl Interference Screws
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories
Regulatory Class: II Product Code: MAI, HTY, HWC Dated: July 15, 2009
Received: July 16, 2009
Dear Ms. Liu
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 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2- Ms. Zheng Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: RigidFix Biocryl Cross Pin Kits BioIntrafix Tibial Tapered Sheaths and Screws Biocryl Interference Screws
Indications for Use:
RigidFix Biocryl Cross Pin Kits
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.
The RigidFix Biocryl Fcmoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
BioIntrafix Tibial Tapered Sheaths and Screws
The BioIntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
Biocryl Interference Screws
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts gr bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
| (Division Sign-Off) |
|---|
| Division of Surgical, Orthopedic, |
| and Restorative Devices |
| /09/04/ |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
51Qtkz Npggccccuntor Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of_1
Premarket Notification: Traditional RigidFix Biocryl Cross Pin Klts, Biocryl Interference Screws, BioIntrafix Tibial Tapered Sheaths and Screws