(194 days)
Not Found
No
The device description and intended use are for mechanical bone fixation devices (screws, guide wires, staples). There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes.
The device is used for fixation of bone fractures and reconstruction, aiming to treat and repair medical conditions.
No
The device descriptions and intended uses clearly state that these are orthopedic implants (screws, guide wires, staples) used for fixation and reconstruction of bones and fractures, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical implants made of titanium (screws, guide wires, staples) intended for bone fixation. There is no mention of software as the primary or sole component of the device.
Based on the provided information, no, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Z-Medical devices described are implants and surgical tools used for the physical fixation and reconstruction of bone fractures and bone fragments within the body. They are used in vivo (within a living organism), not in vitro (in a test tube or laboratory setting).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The devices are purely mechanical in function.
Therefore, these devices fall under the category of surgical implants and instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Z-Snap Off Screw
The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- . Fixation of small bone fragments
- . Weil osteotomy
- Mono-cortical fixation .
- . Osteotomies and fractures fixation in the foot and hand
Z-Double Compression Screw
The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:
- ◆ Fixation of bone fragments or small bone fractures
- . Fracture management in the foot and hand
- Arthrodesis in hand, foot or ankle surgery .
- . Mono or Bi-cortical osteotomies in the foot and hand
Z-Guide Wire
The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Z-Staple
The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:
- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDR, HTY
Device Description
Z-Snap Off Screw
Main application of the Snap Off Screw is the forefoot surgery. The device is intended to connect bones or bone fragments. Especially in the classic "Well"-osteotomy you can fix the two parts of bones with this kind of screw.
Material: ASTM F136 (Ti-6AI-4V ELI) Length: 11 mm to 14 mm Diameter: 2 mm
Z-Double Thread Compression Screw
The Double thread compression screw is mainly used in the forefoot surgery. Most common use is in the "Scart"-osteotomy. They are cannulated to work with a guide wire and they are drilled in manually.
Material: ASTM F136 (Ti-6Al-4V ELI) Length: 10 mm to 36 mm Diameter: 3 and 4 mm
Z-Guide Wire
Guide wires are used in all fields of surgery. Main applications are: determine the correct position for e.g. screws or drills, or fixation of bones, fragments. They are usually put in by machine. Guide wires are also used to drill holes, e.g. to apply staples.
Material: ASTM F 138 (1.4441)
Length: 80 mm to 380 mm
Diameter: 0.7 mm to 6.35 mm
End Styles: Trocar
Type: Smooth
Z-Staple
Staples are implants for fixing bones or fragments. Z-Staples use the SnapOff-technology by Z-Medical. The distal end of the staple can be uses as drilling gauge as well as grip to put in the staple. After reaching the final position, the grip can be snapped off by moving sideways.
Material: ASTM F136 (Ti-6Al-4V ELI) Size: 8 mm to 25 mm Method of insertion: Staple inserter and SnapOff technique
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones or bone fragments, foot and hand, ankle
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)
Testing in order to help establish safety and effectiveness of Z-Medical's bone fixation devices has been performed accordingly and results are conforming to the respective requirements.
- . Z-SnapOff: Torque test, break-off test, sideways stability test, maximum torque test
- Z-Double Compression Screw: Screw-in test, screw compression test, maximum torque test .
- Z-Staple: ASTM F564-10 test, break-off test .
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.
K050819, K091118, K050636, K100736, K043059, K962705
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 shows a logo with the letter Z. The word "MEDICAL" is written diagonally across the letter Z. The text "GMBH + CO.KG" is written below the letter Z. The logo appears to be for a medical company.
NOV 7 2012
510(k) Summary
DATE OF APPLICATION: 2012-04-25
APPLICANT:
Z-Medical GmbH & Co. KG Gänsäcker 38 78532 Tuttlingen Germany Tel.: +49 7462 9455 40 Fax: +49 7462 9455 49
E-Mail: info@z-medical.de www.z-medical.de
CONTACT PERSON:
Alexander Henninger Quality Manager Tel.: +49 7462 9455 40 Fax: +49 7462 9455 49
SECTION_05_510K_Summary_vB.doc
1
Image /page/1/Picture/1 description: The image shows a logo with the letter Z in a stylized, geometric design. The word "MEDICAL" is written diagonally across the center of the Z, and the text "GMBH & CO. KG" is located at the bottom of the logo. The logo appears to be for a medical company or organization.
Device Name 1.
.
Snap Off Screw 1.1.
| Trade Names: | Z-Snap Off Screw |
|---|---|
| Common Name: | Snap Off Screw |
| Classification Name: | Screw, fixation, bone |
Double Thread Compression Screw 1.2.
| Trade Names: | Z-Double Thread Compression Screw |
|---|---|
| Common Name: | Double Thread Compression Screw |
| Classification Name: | Screw, fixation, bone |
1.3. Guide Wire
| Trade Names: | Z-Guide Wire |
|---|---|
| Common Name: | Guide Wire, Kirschner |
| Classification Name: | Pin, fixation, smooth |
1.4. Staple
| Trade Names: | Z-Staple |
|---|---|
| Common Name: | Staple |
| Classification Name: | Staple, fixation, bone |
2. Classification Product Code / Subsequent Code
2.1. Z-Snap Off Screw
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-----------------------|----------------------|--------------|--------------|--------------|-------------------|
| Screw, fixation, bone | Part 888 | Orthopedic | HWC | 2 | 888.3040 |
2.2. Z-Double Thread Compression Screw
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-----------------------|----------------------|--------------|--------------|--------------|-------------------|
| Screw, fixation, bone | Part 888 | Orthopedic | HWC | 2 | 888.3040 |
2.3. Z-Guide Wire
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-----------------------|----------------------|--------------|--------------|--------------|-------------------|
| Pin, fixation, smooth | Part 888 | Orthopedic | HTY | 2 | 888.3040 |
Z-Staple 2.4.
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-----------------------|----------------------|--------------|--------------|--------------|-------------------|
| Screw, fixation, bone | Part 888 | Orthopedic | JDR | 2 | 888.3030 |
2
Image /page/2/Picture/1 description: The image shows a logo with the letter Z in a stylized, geometric design. The word "MEDICAL" is written diagonally across the Z. Below the Z, there is text that reads "GMBH + CO. KG" in a smaller font size. The logo appears to be for a medical company.
3. Predicate Device
Z-Medical's bone fixation devices are substantially equivalent to the following predicate devices, most recently cleared by the FDA:
| Z-Medical Device | Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| Z-Snap Off Screw | CHARLOTTE Snap-Off Screw | K050819 | Wright Medical Technology |
| Z-Double Thread | |||
| Compression Screw | Foot and Hand Motion System | ||
| Synthes 3.0 mm Headless Compression | |||
| Screw | K091118 | ||
| K050636 | NewClip Technics | ||
| Synthes (USA) | |||
| Z-Guide wire | Orthopaedic Fixation Pins and Wires / | ||
| Kirschner / Guide Wires | K100736 | SMT Schilling Metalltechnik GmbH | |
| Z-Staple | Compression Staple and Simple Staple | ||
| MLI Modular Staples | K043059 | ||
| K962705 | Wright Medical Technology | ||
| Medicine Lodge Inc. |
4. Description of the Device
Z-Snap Off Screw 4.1.
Main application of the Snap Off Screw is the forefoot surgery. The device is intended to connect bones or bone fragments. Especially in the classic "Well"-osteotomy you can fix the two parts of bones with this kind of screw.
Material: ASTM F136 (Ti-6AI-4V ELI) Length: 11 mm to 14 mm Diameter: 2 mm
4.2. Z-Double Thread Compression Screw
The Double thread compression screw is mainly used in the forefoot surgery. Most common use is in the "Scart"-osteotomy. They are cannulated to work with a guide wire and they are drilled in manually.
Material: ASTM F136 (Ti-6Al-4V ELI) Length: 10 mm to 36 mm Diameter: 3 and 4 mm
4.3. Z-Guide Wire
Guide wires are used in all fields of surgery. Main applications are: determine the correct position for e.g. screws or drills, or fixation of bones, fragments. They are usually put in by machine. Guide wires are also used to drill holes, e.g. to apply staples.
| Material: | ASTM F 138 (1.4441) |
|---|---|
| Length: | 80 mm to 380 mm |
| Diameter: | 0.7 mm to 6.35 mm |
| End Styles: | Trocar |
| Type: | Smooth |
Z-Staple 4.4.
Staples are implants for fixing bones or fragments. Z-Staples use the SnapOff-technology by Z-Medical. The distal end of the staple can be uses as drilling gauge as well as grip to put in the staple. After reaching the final position, the grip can be snapped off by moving sideways.
3
Z-Medical GmbH & Co. KG
SnapOff Screw, Double Thread Compression Screw, Guide Wire, Staple 510(k) Premarket Notification
Image /page/3/Picture/2 description: The image shows a logo with a stylized letter Z. The word "MEDICAL" is written diagonally across the Z, enclosed in parentheses. Below the Z, the text "GMBH + CO. KG" is present, indicating a German company structure. The logo appears to be for a medical-related company.
ASTM F136 (Ti-6Al-4V ELI) Material: Size: 8 mm to 25 mm Method of insertion: Staple inserter and SnapOff technique
5. Indications for Use
5.1. Z-Snap Off Screw
The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- . Fixation of small bone fragments
- . Weil osteotomy
- Mono-cortical fixation .
- . Osteotomies and fractures fixation in the foot and hand
Z-Double Compression Screw 5.2.
The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:
- ◆ Fixation of bone fragments or small bone fractures
- . Fracture management in the foot and hand
- Arthrodesis in hand, foot or ankle surgery .
- . Mono or Bi-cortical osteotomies in the foot and hand
5.3. Z-Guide Wire
The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
5.4. Z-Staple
The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:
- Fixation of bone fragments or small bones fractures .
- . Fracture management in the foot and hand
4
Image /page/4/Picture/1 description: The image shows a logo with the word "MEDICAL" written diagonally across a stylized letter "Z". Below the "Z", the text "ONAH CO.KR" is visible. The logo appears to be for a medical company or organization, possibly based in Korea, given the ".KR" domain extension.
6. Testing
Testing in order to help establish safety and effectiveness of Z-Medical's bone fixation devices has been performed accordingly and results are conforming to the respective requirements.
- . Z-SnapOff: Torque test, break-off test, sideways stability test, maximum torque test
- Z-Double Compression Screw: Screw-in test, screw compression test, maximum torque test .
- Z-Staple: ASTM F564-10 test, break-off test .
7. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, Z-Medical's bone fixation devices are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.
There are no differences between the devices which would raise new issues of safety or effectiveness.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 7, 2012
Z-Medical GmbH & Co. KG % Mr. Alexander Henninger Quality Manager Gänsäcker 38 Tuttlingen, Baden-Wuerttemberg Germany 78532
Re: K121277
Trade/Device Name: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire. Z-Staple
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, HTY Dated: October 25, 2012 Received: October 25, 2012
Dear Mr. Henninger:
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
6
Page 2 - Mr. Alexander Henninger
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/1 description: The image shows a logo with the word "MEDICAL" in bold, uppercase letters diagonally across a stylized shape. Below the shape, there is text that appears to read "GMBH + CO.KG" in a smaller, sans-serif font. The logo has a simple, geometric design and the text is arranged to fit neatly beneath the graphic element.
K121277
Indications for Use Statement
Device Name: Z-Snap Off Screw
Indications for Use:
The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of small bone fragments ●
- . Weil osteotomy
- . Mono-cortical fixation
- Osteotomies and fractures fixation in the foot and hand t
Prescription Use _ YES (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121277
SECTION04x01IFUStatementSnapOffScrewv02.doc Page 1 of 1
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Image /page/8/Picture/1 description: The image shows a logo for a company called "Z Medical GmbH & Co. KG". The logo features the letter "Z" in a bold, stylized font, with the word "MEDICAL" written across the middle of the "Z". The text "GmbH & Co. KG" is written in a smaller font below the "Z".
K121277
Indications for Use Statement
Device Name: Z-Double Thread Compression Screw
Indications for Use:
The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included:
- Fixation of bone fragments or small bone fractures .
- Fracture management in the foot and hand .
- Arthrodesis in hand, foot or ankle surgery ●
- Mono or Bi-cortical osteotomies in the foot and hand .
AND/OR Prescription Use _ yEs (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO_ (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121277
SECTION_04_x02_IFU_Statement_DoubleThreadCompressionScrew_v2.doc
Page 1 of 1
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Image /page/9/Picture/1 description: The image shows a logo with the word "MEDICAL" written diagonally across a stylized letter "Z". The text "GMBH + CO. KG" is located at the bottom of the logo. The logo has a simple, geometric design with a bold, sans-serif typeface.
K121277
Indications for Use Statement
Device Name: Z-Guide Wire
Indications for Use:
The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Prescription Use __ YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121277
SECTION_04_x03_1FU_Statement_GuideWire_v02.doc
Page 1 of 1
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Image /page/10/Picture/1 description: The image shows a logo with the word "MEDICAL" written diagonally across a stylized letter "Z". Below the "Z", the text "DMSK + OD.KO" is written in a smaller font. The logo appears to be for a medical-related company or organization. The image is in black and white.
K121277
Indications for Use Statement
Device Name: Z-Guide Staple
Indications for Use:
The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included:
- Fixation of bone fragments or small bones fractures .
- Fracture management in the foot and hand .
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
SECTION_04_x04_IFU_Statement_Staple_v2.doc