510(k) · Cleared
ClearedLorenz Orthodontic Anchorage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Feb 9, 2007 as substantially equivalent to K040891 (KLS-Martin L.P., 2004) and 4 other predicates after a 93-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Feb 9, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K954385 (1996). 30 ancestors in all, the oldest K820944 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 4 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 3 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 2 generations backK022185 Universal CMF SystemStryker Instruments · 2002
- 1 generation backK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- This deviceK063386 Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −4 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −3 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −2 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| −1 | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| 0 (this device) | K063386 | Lorenz Orthodontic Anchorage System | Walter Lorenz Surgical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 3 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OAT device
- #1 K260268 OrthoEasy Pal; OrthoEasy Pal Long Neckscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040891 | KLS Martin Ortho Anchorage System (Plates)Summary page 1…ial Equivalence: The Lorenz Orthodontic Anchorage -System is believed to be substantially equivalent in application and function to the KLS-Martin Ortho Anchorage System K040891, the Stryker Leibinger Skeletal Anchoring System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm… | 2004 |
| * | K041651 | Stryker Leibinger Skeletal Anchoring SystemSummary page 1…is believed to be substantially equivalent in application and function to the KLS-Martin Ortho Anchorage System K040891, the Stryker Leibinger Skeletal Anchoring System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm System K953385 and to the Lorenz IMF and Self-Drilling I… | 2004 |
| * | K953385 | Lorenz 1.0MM, 1.5MM, 2.0MM SystemSummary page 1…n Ortho Anchorage System K040891, the Stryker Leibinger Skeletal Anchoring System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm System K953385 and to the Lorenz IMF and Self-Drilling IMF Screws K983728 and K040983.… | 1995 |
| * | K983728 | Lorenz Imf ScrewSummary page 1…letal Anchoring System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm System K953385 and to the Lorenz IMF and Self-Drilling IMF Screws K983728 and K040983. 9 === Page 2 ==… | 1999 |
| * | K040983 | Lorenz Self-Drilling Imf ScrewSummary page 1…ing System K041651, the Lorenz Craniofacial/Neuro Bone Plates and Screws 1.0, 1.5 and 2.0mm System K953385 and to the Lorenz IMF and Self-Drilling IMF Screws K983728 and K040983. 9 IT "… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 30 ancestors have a recall of any class.
- 4 other devices also cite its predicate K040891.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OAT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAT
224in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAT
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAT
5in 2025
MAUDE reports naming product code OAT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 104 | 2 | 2 |
| 2008 | 3 | 94 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 152 | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 289 | 0 | 38 |
| 2021 | 4 | 224 | 0 | 68 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063386: Lorenz Orthodontic Anchorage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063386
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026