(11 days)
No
The device description focuses on the mechanical design and material properties of a resorbable screw, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a therapeutic device as it is used to treat fractures and perform reconstructive procedures in the midface and craniofacial skeleton.
No
Explanation: The device is a resorbable screw intended for use in midface and craniofacial surgical procedures to secure bone. It is an implantable surgical device, not a device used for diagnosis.
No
The device description clearly states it is a physical screw made of a resorbable copolymer, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a screw for fixing bones in the midface and craniofacial skeleton during surgical procedures (trauma and reconstructive). This is an in-vivo application, meaning it's used within the living body.
- Device Description: The description details the physical characteristics of a screw made from a resorbable copolymer. This is a surgical implant, not a device used to examine specimens from the human body.
- 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
- Using reagents or assays
- Performing tests outside of the body
The device is a surgical implant used for mechanical fixation of bone.
N/A
Intended Use / Indications for Use
The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- Comminuted fractures of the naso-ethmoidal infraorbital areas 1.
- Comminuted fractures of the frontal sinus wall 2.
- Pediatric midface or craniofacial trauma 3.
-
- LeFort (I, II, II) fractures
-
- Orbital floor fractures
-
- Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
- Trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones.
- B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
-
- LeFort (1, II, II, II) osteotomies
-
- Tumor reconstruction in midface or craniofacial procedures
-
- Bone graft procedures in the midface or craniofacial skeleton
-
- Pediatric reconstructive procedures
- Reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones
-
- Craniotomy flap fixation
-
This system is not designed for use in the mandible and/or full load bearing procedures.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.
Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.
Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids
Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.
The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface, craniofacial skeleton, naso-ethmoidal infraorbital areas, frontal sinus wall, orbital floor, maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, lacrimal bones, frontal, parietal, temporal, sphenoid, occipital bones
Indicated Patient Age Range
pediatric, infant
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)
Not Found
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.
K971870, K002423, K992355, K992158, K960988, K955729, K981666
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
MAY 2 1 2002
Summary of Safety and Effectiveness
Lorenz Lactosorb® 1.5 mm x 4 mm Tap Free Screw
Walter Lorenz Surgical, Inc. Submitter: 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Establishment Registration: 1032347
Contact Person: Sheryl Malmberg Regulatory Affairs (904)-741-4400
Trade Name: Lorenz 1.5 x 4 mm Lactosorb® Tap Free Screw
Common or Usual Name: Resorbable Bone Screw
Classification Name: Screw, Fixation, Intraosseous (21 CFR 872.4880)
Device Classification: Class II
Device Product Code: DZL
Indications for Use:
The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- Comminuted fractures of the naso-ethmoidal infraorbital areas 1.
- Comminuted fractures of the frontal sinus wall 2.
- Pediatric midface or craniofacial trauma 3.
-
- LeFort (I, II, II) fractures
-
- Orbital floor fractures
-
- Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
- Trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones.
1
- B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
-
- LeFort (1, II, II, II) osteotomies
-
- Tumor reconstruction in midface or craniofacial procedures
-
- Bone graft procedures in the midface or craniofacial skeleton
-
- Pediatric reconstructive procedures
- Reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones
-
- Craniotomy flap fixation
-
This system is not designed for use in the mandible and/or full load bearing procedures.
Device Description: The device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.
Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.
Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids
Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.
The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.
000048
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
21 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheryl Malmberg Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re: K021522
Trade/Device Name: Lorenz 1.5 mm x 4.0 mm Lactosorb® Tap Free Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: Class II Product Code: DZL Dated: May 08, 2002 Received: May 10, 2002
Dear Ms. Malmberg:
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 such 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.
3
Page 2 - Ms. Sheryl Malmberg
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. or the Fee of all , I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and inoms (2) roquiceller as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dspamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number K021522
Device Name: Lorenz 1.5 mm x 4mm Lactosorb® Tap Free Screw
Indications for Use:
The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
-
- Comminuted fractures of the naso-ethmoidal infraorbital areas
-
- Comminuted fractures of the frontal sinus wall
-
- Pediatric midface or craniofacial trauma
-
- LeFort (1, II, II) fractures
-
- Orbital floor fractures
-
- Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
-
- Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
-
- B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
Specific Indications:
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
-
- LeFort (I, II, II) osteotomies
-
- Tumor reconstruction in midface or craniofacial procedures
-
- Bone graft procedures in the midface or craniofacial skeleton
-
- Pediatric reconstructive procedures
-
- Reconstructive procedures of the craniofacial skeleton including: frontal. parietal, temporal, sphenoid, and occipital bones
-
- Craniotomy flap fixation
This system is not designed for use in the mandible and/or full load bearing procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
SORRump OR Over-The-Counter-Use
(Division Sign-Off) ~~(Optional Format 1-2-96) ~~
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K021522
000006