510(k) · Cleared
Recalled · Class II · 2015Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pega Medical, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 27, 2013 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 4 other predicates after a 180-day review. Its family tree reaches back 5 generations to 1990. It has been recalled 2 times.
- Decided
- Nov 27, 2013
- Review
- 180 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 5 generations to K903810 (1990). 17 ancestors in all, the oldest K760454 (1976). No later device cites it as a predicate yet.
- Root · 5 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 4 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 3 generations backK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
- 2 generations backK080649 Pogo ScrewFxdevices · 2008
- 1 generation backK092189 Pogo ScrewFxdevices · 2009
- This deviceK131591 Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −4 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −3 | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | 1 |
| −2 | K080649 | Pogo Screw | Fxdevices | 2008 | — |
| −1 | K092189 | Pogo Screw | Fxdevices | 2009 | — |
| 0 (this device) | K131591 | Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) | Pega Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (5)
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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 2…K 13 1591 1. Synthes 6.5 mm Cannulated Screw (Stainless Steel screws), Synthes USA. (K021 932) 2. Hansson Pin System (Ti alloy nail and Stainless Steel screws & end caps), Howmedica Osteonics Corporation. (K96… | 2002 |
| * | K964893 | Hansson Pin SystemSummary page 2…eel screws), Synthes USA. (K021 932) 2. Hansson Pin System (Ti alloy nail and Stainless Steel screws & end caps), Howmedica Osteonics Corporation. (K964893 & K033968) 3. POGO Screw (Stainless Steel screws), FxDevices. (K092189 & K080649) The intended uses of these devic… | 1997 |
| * | K033968 | Hansson Pin SystemSummary page 2…), Synthes USA. (K021 932) 2. Hansson Pin System (Ti alloy nail and Stainless Steel screws & end caps), Howmedica Osteonics Corporation. (K964893 & K033968) 3. POGO Screw (Stainless Steel screws), FxDevices. (K092189 & K080649) The intended uses of these devices are the… | 2004 |
| * | K092189 | Pogo ScrewSummary page 2…alloy nail and Stainless Steel screws & end caps), Howmedica Osteonics Corporation. (K964893 & K033968) 3. POGO Screw (Stainless Steel screws), FxDevices. (K092189 & K080649) The intended uses of these devices are the same as the Free Gliding SOFE Screw System Summary of Technologie… | 2009 |
| * | K080649 | Pogo ScrewSummary page 2…inless Steel screws & end caps), Howmedica Osteonics Corporation. (K964893 & K033968) 3. POGO Screw (Stainless Steel screws), FxDevices. (K092189 & K080649) The intended uses of these devices are the same as the Free Gliding SOFE Screw System Summary of Technologies: The technologic… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2015 | Class II | Z-0324-2016 | Unknown/Undetermined by firm | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. |
| Jun 15, 2015 | Class II | Z-1848-2015 | Reprocessing Controls | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 61 other devices also cite its predicate K021932.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131591 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131591: Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131591
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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