510(k) · Cleared
ClearedProRib Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Costa Surgical, Inc. · HRS Plate, Fixation, Bone
Cleared on Sep 23, 2026 as substantially equivalent to K203474 (Biomet Micofixation, 2021) and 2 other predicates after a 110-day review. Its family tree reaches back 16 generations to 1976.
- Decided
- Sep 23, 2026
- Review
- 110 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K761228 (1976). 126 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 12 generations between
- 3 generations backK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 2 generations backK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 1 generation backK212608 RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2022
- This deviceK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 15 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 14 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 13 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 12 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 11 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 10 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 9 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 8 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 7 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 6 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- 5 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- 4 generations backK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- 3 generations backK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 2 generations backK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 1 generation backK212608 RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2022
- This deviceK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −15 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −14 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −13 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −12 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −11 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −10 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −9 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −8 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −7 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −6 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| −5 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −4 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −3 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| −2 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| −1 | K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2022 | — |
| 0 (this device) | K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K203474 | Biomet Microfixation RibFix Advantage SystemSummary page 5…eaded metallic bone fixation fastener Class: II Product Codes: HRS, HWC, HTN Primary Predicate: K203474 - Biomet Microfixation RibFix Advantage System Additional Predicate: K212608 - Biomet Microfixation RibFix Blu Thoracic Fi… | 2021 |
| * | K212608 | RibFix Blu Thoracic Fixation SystemSummary page 5…II Product Codes: HRS, HWC, HTN Primary Predicate: K203474 - Biomet Microfixation RibFix Advantage System Additional Predicate: K212608 - Biomet Microfixation RibFix Blu Thoracic Fixation System K222397 - KLS… | 2022 |
| * | K222397 | KLS Martin Level One Rib Fixation SystemSummary page 5…Advantage System Additional Predicate: K212608 - Biomet Microfixation RibFix Blu Thoracic Fixation System K222397 - KLS Martin L1 PEEK Rib Fixation System Reference Devices: • K153482 – KLS Martin Thoracic Plating System • K232515 - Ab… | 2023 |
| † | K153482 | KLS Martin Thoracic Plating System | 2016 |
| † | K232515 | Valkyrie Thoracic Fixation System | 2023 |
| † | K081623 | Synthes Rib Fixation System | 2008 |
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 50 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 126 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203474.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ProRib Fixation System extrathoracic plates and locking screws are indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.
The ProRib Fixation System intrathoracic implants are indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261892: ProRib Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261892
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026