510(k) · Cleared
ClearedLorenz Sternal Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 18, 2006 as substantially equivalent to K011076 (Walter Lorenz Surgical, Inc., 2001) and 3 other predicates after a 28-day review. Its family tree reaches back 7 generations to 1976. 87 later devices descend from it.
- Decided
- Dec 18, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K761228 (1976). 20 ancestors in all. 87 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 2 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 1 generation backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- This deviceK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- Descendant · cites it directly · 84 of its ownK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- Descendant · cites it directly · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- Descendant · 2 generations on · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- Descendant · 2 generations on · 46 of its ownK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 2 generations on · 45 of its ownK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly84descendants
- K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly78descendants
- K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · 2 generations on75descendants
- K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012 · 2 generations on46descendants
- K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · 2 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −2 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −1 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| 0 (this device) | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| +1 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| +1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +2 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +2 | K122293 | Pioneer Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +2 | K133785 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2014 | 1 |
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 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K011076 | Lorenz Sternal Closure System with Modular Screw Our reading of the summary gave K001076, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lorenz Sternal Closure System”. | 2001 |
| * | K033740 | Lorenz Sternal Closure SystemSummary page 1…uded in the package insert. Substantial Equivalence: Walter Lorenz considers the Lorenz Sternal Closure System equivalent to Lorenz Sternal Closure System (KO011076 and K033740), Lorenz Self Drilling Screw (K013954) and Lorenz 2.4 Self Drilling Screw (K032228). Possible risks: 1. Poor bone formation, Ost… | 2003 |
| * | K013954 | Lorenz Self Drilling ScrewsSummary page 1…al Equivalence: Walter Lorenz considers the Lorenz Sternal Closure System equivalent to Lorenz Sternal Closure System (KO011076 and K033740), Lorenz Self Drilling Screw (K013954) and Lorenz 2.4 Self Drilling Screw (K032228). Possible risks: 1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis,… | 2002 |
| * | K032228 | Lorenz 2.4 Self Drilling ScrewsSummary page 1…orenz Sternal Closure System equivalent to Lorenz Sternal Closure System (KO011076 and K033740), Lorenz Self Drilling Screw (K013954) and Lorenz 2.4 Self Drilling Screw (K032228). Possible risks: 1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can… | 2003 |
What descends from it? (87)
See all 873 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K110574 (Biomet Microfixation, Inc., 2011) has gone furthest, with 84 descendants of its own.
- 8 other devices also cite its predicate K011076.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063506: Lorenz Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063506
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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