(87 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the plates and screws, with no mention of AI or ML.
Yes.
The device, consisting of implants like plates and screws, is intended to support normal bone healing for osteotomies, fractures, and reconstructions, indicating its role in treating medical conditions or injuries.
No
The device description clearly states that the RECON system is a "plate and screw system intended for internal fixation" to support normal bone healing for osteotomies, fractures, and reconstructions. This describes a therapeutic device used in surgical procedures, not a diagnostic device which primarily identifies diseases or conditions.
No
The device description clearly states it is a "plate and screw system" made of titanium alloy or commercially pure Titanium, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the implants are for supporting bone healing for osteotomies, fractures, and reconstructions, and for fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. This describes a surgical implant used directly on the patient's body.
- Device Description: The device is described as a "plate and screw system intended for internal fixation." This further confirms it's an implant for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Gruber Lapidus
The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.
Plantar Lapidus
The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.
Tarsalis
The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.
Product codes
HRS, HWC
Device Description
The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:
- Gruber Lapidus Plates 2.7, .
- . Plantar Lapidus Plates 2.7,
- Tarsalis Plates 2.7, ●
- Locking Screws 2.7 ●
- Standard Screws 2.7
- Minican Screws 2.7/3.5
of different sizes and designs.
The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
TMT I joint, forefoot and midfoot.
Indicated Patient Age Range
The system can be used in both adult and pediatric patients.
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)
- Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed.
- Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatique strength of the RECON System-Tarsalis Plates, the Lapidus Gruber Plates and the Plantar Lapidus Plates and the predicate devices, the Modular Foot System – 2.7 mm Module (K010321), Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710), and Zimmer Plates and Screws System (ZPS) (K143066) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- Bending strength engineering analysis for Minican Screws 2.7 mm and Minican Screws 3.5 mm (Partially-Treaded and Fully Threaded) and the predicate devices, the ZimmerBiomet Herbert Mini Bone screw (K143165) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- Self-tapping performance, driving and removal torque, to failure and axial pullout of the -RECON System - Locking Screws 2.7mm, Standard Screws 2.7mm, MiniCAN Screws 2.7mm and MiniCAN Screws 3.5mm (Partial Thread) and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) and Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw (K143165), resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010321, K063303, K060710, K143066, K143165, K151407, K152142
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird in flight.
November 5, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NORMED Medizin-Tecknik GmbH Mr. Arne Briest Regulatory Affairs Manager Ulrichstrasse 7 D-78532 Tuttlingen GERMANY
Re: K152256 Trade/Device Name: RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 7, 2015 Received: August 10, 2015
Dear Mr. Briest:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Arne Briest
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152256
Device Name
RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws
Indications for Use (Describe)
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Gruber Lapidus
The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.
Plantar Lapidus
The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.
Tarsalis
The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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Image /page/4/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "The specialist for small bones" above the word "NORMED" in a stylized font. Below the word "NORMED" is the text "A ZIMMER COMPANY" with a Zimmer logo.
510(k) Summary
1. Submission Sponsor and Correspondent
| Normed Medizin-Technik GmbH |
|---|
| Ulrichstrasse 7 |
| D-78532 Tuttlingen |
| Germany |
| Phone: | + 49 7461 93 43 0 |
|---|---|
| Fax: | + 49 7461 93 43 20 |
| Contact: | Mr. Arne Briest |
FDA Establishment Registration #:
Date Prepared 2.
Date Prepared:
November 2, 2015
9611091
Device Identification 3.
| Trade/Proprietary Name: | RECON system - Gruber Lapidus-, Plantar Lapidus-,
Tarsalis Plates and Screws |
|---------------------------|---------------------------------------------------------------------------------|
| Common/Usual Name: | bone plate and screw |
| Classification Name: | Plate, Fixation, Bone |
| | Screw, Fixation, Bone |
| Classification Regulation | 21CFR 888.3030 |
| | 21CFR 888.3040 |
| Product Code: | HRS |
| | HWC |
| Device Class: | Class II |
| Classification Panel | Orthopedic |
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Image /page/5/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "The specialist for small bones" above the NORMED logo. The NORMED logo is in a bold, sans-serif font, with a globe in the center of the "O". Below the NORMED logo is the text "A ZIMMER COMPANY" with a blue Z logo.
4. Legally Marketed Predicate Device
K010321 - Modular Foot System - 2.7 mm Module, manufactured by Synthes Inc., cleared May 2, 2001
K063303 - Universal Locking Plate System 2.7, Plates and Screws, manufactured by Zimmer Inc., cleared November 22, 2006
K060710 - Universal Locking Plate System 3.5, Plates and Screws manufactured by Zimmer Inc., cleared April 26, 2006
K143066 - Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers, manufactured by Zimmer Inc., cleared November 28, 2014
K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw, manufactured by Zimmer Inc., cleared March 31, 2015
K151407 - Recon System, manufactured by Normed Medizin-Technik GmbH, cleared August 12, 2015
K152142 - Recon System-MPJ-Plates, manufactured by Normed Medizin-Technik GmbH, cleared September 16, 2015
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Image /page/6/Picture/2 description: The image is a logo for NORMED, "The specialist for small bones", which is "A ZIMMER COMPANY". The logo is black and white, with the word "NORMED" in large, bold letters. The "O" in "NORMED" is replaced by a target symbol with a world map in the center. The words "The specialist for small bones" are above the word "NORMED", and the words "A ZIMMER COMPANY" are below the word "NORMED".
5. Device Description
The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:
- Gruber Lapidus Plates 2.7, .
- . Plantar Lapidus Plates 2.7,
- Tarsalis Plates 2.7, ●
- Locking Screws 2.7 ●
- Standard Screws 2.7
- Minican Screws 2.7/3.5
of different sizes and designs.
The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
7
Image /page/7/Picture/2 description: The image is a logo for Normed, a Zimmer company. The logo is black and white and features the word "NORMED" in a bold, sans-serif font. Above the word "NORMED" is the tagline "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".
6. Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Gruber Lapidus
The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.
Plantar Lapidus
The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.
Tarsalis
The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.
7. Substantial Equivalence Discussion
The RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws have the same intended use, similar performance characteristics, is manufactured from similar materials and is similar in design to the predicate devices.
8
Traditional 510(k)
Image /page/8/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the word "NORMED" in a bold, stylized font, with an image of the earth inside the letter "O". Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY" with a stylized Z to the left.
8. Non-Clinical Performance Data
- -Biocompatibility - Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed.
- -Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatique strength of the RECON System-Tarsalis Plates, the Lapidus Gruber Plates and the Plantar Lapidus Plates and the predicate devices, the Modular Foot System – 2.7 mm Module (K010321), Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710), and Zimmer Plates and Screws System (ZPS) (K143066) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- Bending strength engineering analysis for Minican Screws 2.7 mm and Minican Screws 3.5 mm (Partially-Treaded and Fully Threaded) and the predicate devices, the ZimmerBiomet Herbert Mini Bone screw (K143165) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- Self-tapping performance, driving and removal torque, to failure and axial pullout of the -RECON System - Locking Screws 2.7mm, Standard Screws 2.7mm, MiniCAN Screws 2.7mm and MiniCAN Screws 3.5mm (Partial Thread) and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) and Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw (K143165), resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
9. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device.
9
Image /page/9/Picture/2 description: The image is a logo for NORMED, "The specialist for small bones", which is a Zimmer company. The logo is black and white, with the word "NORMED" in large, bold letters. The "O" in NORMED is a globe with a target over it. Below the word "NORMED" is the text "A ZIMMER COMPANY".
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the RECON system -Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and the predicate devices do not raise any questions regarding its safety and effectiveness.
Performance testing and compliance with voluntary standards, demonstrate that the RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
The RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws are determined to be substantially equivalent to the referenced predicate devices.