510(k) · Cleared
ClearedOsteo Compression Condyle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · HWC Screw, Fixation, Bone
Cleared on Dec 7, 1998 as substantially equivalent to K971321 (Osteonics Corp., 1997) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 7, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920037 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920037 Osteo Compression Hip ScrewOsteo AG · 1992
- This deviceK983508 Osteo Compression Condyle Screw SystemOsteonics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920037 | Osteo Compression Hip Screw | Osteo AG | 1992 | — |
| 0 (this device) | K983508 | Osteo Compression Condyle Screw System | Osteonics Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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 |
|---|---|---|---|
| * | K971321 | Osteo Compression Condyle Screw SystemSummary page 1…sories 21 CFR §888.3030 Predicate Device Identification The Osteo Compression Condyle Screw System has previously been determined substantially equivalent via 510(kOs #K971321 and #K920037. The expanded indications are substantially equivalent to those of the Synthes® Dynamic Condylar Screw System. Devi… | 1997 |
| * | K920037 | Osteo Compression Hip ScrewSummary page 1…§888.3030 Predicate Device Identification The Osteo Compression Condyle Screw System has previously been determined substantially equivalent via 510(kOs #K971321 and #K920037. The expanded indications are substantially equivalent to those of the Synthes® Dynamic Condylar Screw System. Device Descriptio… | 1992 |
| * | — | Synthes Dynamic Condylar Screw System Named without a submission number |
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?
- None of the 2 ancestors has a recall.
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?
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#£913269) may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for…
Read the full statement (175 words)
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#£913269) may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.
Intercondylar fractures
Supracondylar fractures
Unicondylar fractures
Fractures of the proximal femur:
Transverse subtrochanteric fractures
Short oblique subtrochanteric fractures
Long oblique subtrochanteric fractures
The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation and translation of the fracture fragment
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/K983508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983508: Osteo Compression Condyle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983508
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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