510(k) · Cleared
Recalled · 2009Biomet Microfixation Lactosorb Pectus Stabilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation, Inc. · HRS Plate, Fixation, Bone
Cleared on Sep 6, 2007 as substantially equivalent to K981789 (Walter Lorenz Surgical, Inc., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.
- Decided
- Sep 6, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K972420 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- 2 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- 1 generation backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- This deviceK071577 Biomet Microfixation Lactosorb Pectus StabilizerBiomet Microfixation, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| −2 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| −1 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| 0 (this device) | K071577 | Biomet Microfixation Lactosorb Pectus Stabilizer | Biomet Microfixation, Inc. | 2007 | — |
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? (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 |
|---|---|---|---|
| * | K981789 | Lorenz Pectus Support Bar StabilizerSummary page 1…quivalence: The Biomet Microfixation LactoSorb®9 Pectus Stabilizer is believed to be substantially equivalent in application and function to the Lorenz Pectus Stabilizer K98 1789, Lorenz Pectus Support Bar K972420 and Lorenz Pectus Support Bar System K061384. DEPARTMENT OF HEALTH & HUM… | 1998 |
| * | K972420 | Lorenz Pectus Support BarSummary page 1…ant and does not require removal. Intended Use: The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K06 1384 for repairing Pectus Excavatumn and other sternal deformities when additional stabilization is necessary. Materials… | 1997 |
| * | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumSummary page 1…not require removal. Intended Use: The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K06 1384 for repairing Pectus Excavatumn and other sternal deformities when additional stabilization is necessary. Materials Lac… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2009 | Not classified | Z-1323-2009 | Device Design | This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K981789.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071577: Biomet Microfixation Lactosorb Pectus Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071577
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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