510(k) · Cleared
ClearedLorenz Self Drilling Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 28, 2002 as substantially equivalent to K983485 (Synthes (Usa), 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1976. 117 later devices descend from it.
- Decided
- Feb 28, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K761228 (1976). 16 ancestors in all. 117 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 1 generation backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- This deviceK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- Descendant · cites it directly · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- Descendant · 2 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- Descendant · cites it directly · 87 of its ownK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- Descendant · 2 generations on · 84 of its ownK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · cites it directly101descendants
- K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 2 generations on100descendants
- K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006 · cites it directly87descendants
- K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · 2 generations on84descendants
- K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| 0 (this device) | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| +1 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| +2 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| +1 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| +2 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| +2 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 16 | 0 |
| 2025 | 16 | 0 |
| 2026 | 13 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K983485 | Synthes 1.3 MM Self-Drilling ScrewSummary page 1…sert and can be seen in Attachment L Substantial Equivalence: Walter Lorenz considers the Lorenz Self Drilling Screws equivalent to Synthes 1.3MM Self Drilling Screw (K983485), Osteomed Corp. Auto-Drive Bone Screw (K974785), and KLS Martin L.P. Centre-Drive Drill Free Screw (K971297). TAB 3 includes a s… | 1998 |
| * | K974785 | Auto-Drive Bone ScrewSummary page 1…al Equivalence: Walter Lorenz considers the Lorenz Self Drilling Screws equivalent to Synthes 1.3MM Self Drilling Screw (K983485), Osteomed Corp. Auto-Drive Bone Screw (K974785), and KLS Martin L.P. Centre-Drive Drill Free Screw (K971297). TAB 3 includes a substantial equivalence comparison table to compe… | 1998 |
| * | K971297 | Centre-Drive Drill-Free ScrewSummary page 1…ling Screws equivalent to Synthes 1.3MM Self Drilling Screw (K983485), Osteomed Corp. Auto-Drive Bone Screw (K974785), and KLS Martin L.P. Centre-Drive Drill Free Screw (K971297). TAB 3 includes a substantial equivalence comparison table to competitive devices. TAB 4 includes sales information and/or Prema… | 1997 |
What descends from it? (117)
See all 1176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032228 | Lorenz 2.4 Self Drilling Screws | 2003 | 101 |
| K063506 | Lorenz Sternal Closure System | 2006 | 87 |
| K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for… | 2002 | 7 |
| K121589 | Biomet Microfixation Facial Plating System | 2012 | 5 |
| K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | 2003 | 5 |
| K031751 | Rapidfire Self Drilling Screws | 2003 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K032228 (Walter Lorenz Surgical, Inc., 2003) has gone furthest, with 101 descendants of its own.
- 7 other devices also cite its predicate K983485.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013954: Lorenz Self Drilling Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013954
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026