510(k) · Cleared

Cleared

Hip Tool Implant

K022139510(k) TraditionalCleared Sep 23, 200283-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orthopedic Sciences, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 23, 2002 as substantially equivalent to K982222 (Synthes (Usa), 1998) and 14 other predicates after an 83-day review. Its family tree reaches back 3 generations to 1985. 7 later devices descend from it.

Decided: Sep 23, 2002
Review: 83 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 15

Its longest line of descent runs back 3 generations to K850886 (1985). 41 ancestors in all, the oldest K770128 (1977). 7 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
2 generations backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
1 generation backK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
This deviceK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
Descendant · cites it directly · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
Descendant · cites it directly · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK063033 Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006
Descendant · cites it directly · 0 of its ownK052538 S-Bone Hip ToolOrthopedic Sciences, Inc. · 2005

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004high 3 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all

K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · cites it directly1descendant
K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · cites it directly1descendant
K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 2 generations on0descendants
K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006 · 2 generations on0descendants
K052538S-Bone Hip ToolOrthopedic Sciences, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K850886	Compression Hip Screw System	Pfizer, Inc.	1985	1
−2	K955306	Omega+ Compression Screw System	Howmedica Corp.	1996	1
−1	K970258	Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable…	Ferguson Medical	1997	—
0 (this device)	K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	—
+1	K063709	TS-Bone Hip Tool	Orthopedic Sciences, Inc.	2007	—
+1	K040850	Tsy Shoulder Plate Implant	Orthopedic Sciences, Inc.	2004	—
+2	K072175	Titanium Hip Tool Locking Plate	Orthopedic Sciences, Inc.	2007	—
+2	K063033	Modification to Titanium Shoulder Plate Implant	Orthopedic Sciences, Inc.	2006	—
+1	K052538	S-Bone Hip Tool	Orthopedic Sciences, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	1	0
1979	3	0
1987	2	0
1989	1	0
1990	1	0
1991	1	0
1992	4	0
1993	3	0
1994	5	0
1996	2	0
1997	3	0
1998	3	0
1999	2	0
2000	3	0
2001	4	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	3	0
2006	1	0
2007	2	0

FIG. 1 — Lineage of K022139, 1985–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (15)

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	Applicant	Decided	Recalls
*	K982222	Synthes (Usa) Distal Femur Plate (DFP) System Summary page 2 …and cancellous bone grafting to stabilize the resultant intraosseous fracture. Other predicate bone plate based devices are the Synthes Distal Femur Plate (DFP) System (K982222), Synthes Locking Condylar Plate (LCP) System (K000066), BioPro Wujin #3 femoral bone plate (KO1 1459), DuPuy ACE Medical Trochan…	Synthes (Usa)	1998	—
*	K000066	Synthes (Usa) Locking Condylar Plate (LCP) System Summary page 2 …intraosseous fracture. Other predicate bone plate based devices are the Synthes Distal Femur Plate (DFP) System (K982222), Synthes Locking Condylar Plate (LCP) System (K000066), BioPro Wujin #3 femoral bone plate (KO1 1459), DuPuy ACE Medical Trochanteric Side Plate (K970503), Stryker Plating System Basi…	Synthes (Usa)	2000	—
*	K011459	Wujin #3 Femoral Bone Plate	Biopro, Inc.	2001	—
*	K970503	Depuy Ace Trochanteric Side Plate Summary page 2 …(DFP) System (K982222), Synthes Locking Condylar Plate (LCP) System (K000066), BioPro Wujin #3 femoral bone plate (KO1 1459), DuPuy ACE Medical Trochanteric Side Plate (K970503), Stryker Plating System Basic Fragment Set (KO12 162), Metagen High Tibial Osteotomy System (K963700), Smith 510…	Depuy Ace Medical Co.	1997	—
*	K012162	Stryker Plating System Basic Fragment Set	Howmedica Osteonics Corp.	2001	—
*	K963700	Metagen High Tibial Osteotomy System Summary page 2 …l bone plate (KO1 1459), DuPuy ACE Medical Trochanteric Side Plate (K970503), Stryker Plating System Basic Fragment Set (KO12 162), Metagen High Tibial Osteotomy System (K963700), Smith 510(k) Summary Hip Tool'" Implant Page 3 o ,'…	Metagen, LLC	1997	—
*	K993106	Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) Summary page 3 …m (K963700), Smith 510(k) Summary Hip Tool'" Implant Page 3 o ,'3 & Nephew Bone Plate System (K993 106), Syntec-Taichung Medical Instruments Non-sterile Titanium Alloy Mini Plate (K983988) and Ferguson Medical Orthopedic Plate Syste…	Smith & Nephew, Inc.	1999	—
*	K983988	Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate Summary page 3 …lant Page 3 o ,'3 & Nephew Bone Plate System (K993 106), Syntec-Taichung Medical Instruments Non-sterile Titanium Alloy Mini Plate (K983988) and Ferguson Medical Orthopedic Plate System (K9722 19). All of these marketed devices provide stabilization of bone fragments t…	Syntec Scientific Corp.	1999	—
*	K972219	Orthopedic Plate System Summary page 3 …& Nephew Bone Plate System (K993 106), Syntec-Taichung Medical Instruments Non-sterile Titanium Alloy Mini Plate (K983988) and Ferguson Medical Orthopedic Plate System (K9722 19). All of these marketed devices provide stabilization of bone fragments to promote healing of bone. In particular, the Synthes Di…	Ferguson Medical	1997	—
*	K982553	Osteo Compression Hip Screw System Summary page 3 …sm that is intended to stabilize bone fragments. Predicate devices used to stabilize fractures of the femoral neck are the Osteonics Osteo Compression Hip Screw System (K982553), and the Ferguson Medical Fixano D.S.S. System for Osteosynthesis of Unstable Femoral Neck Fractures (K970258). These devices pr…	Osteonics Corp.	1998	—
*	K970258	Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck… Summary page 3 …neck are the Osteonics Osteo Compression Hip Screw System (K982553), and the Ferguson Medical Fixano D.S.S. System for Osteosynthesis of Unstable Femoral Neck Fractures (K970258). These devices provide stabilization of femoral neck fractures to promote healing of bone. Other devices with similar intended…	Ferguson Medical	1997	—
*	K994158	Macrosorbos Protective Sheet Our reading of the summary gave K994155, FDA’s number for Excelsior 1018 Microcatheter (Boston Scientific, Target). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MacroPoreOS Protective Sheet”.	Macropore Biosurgery, Inc.	2000	—
*	K003788	Synthes Resorable Meshes and Sheets Summary page 3 …fractures to promote healing of bone. Other devices with similar intended use include the MacroPoreOS Protective Sheet (K9941SS), Synthes Resorbable Meshes and Sheets (K003788) and Biomet Lactosorb Panels and Fasteners (KO1 1 139 and K984390). These devices maintain position of weak bony tissue, bony fra…	Synthes (Usa)	2001	—
*	K011139	Lorenz Lactosorb Panels and Fasteners	Biomet, Inc.	2001	—
*	K984390	Lactosorb Panels and Fasteners Summary page 3 …intended use include the MacroPoreOS Protective Sheet (K9941SS), Synthes Resorbable Meshes and Sheets (K003788) and Biomet Lactosorb Panels and Fasteners (KO1 1 139 and K984390). These devices maintain position of weak bony tissue, bony fragments, bone grafts and bone graft substitutes, and morselized bon…	Biomet, Inc.	2000	—

Also cleared against K982222: 2 other devices →

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063709	TS-Bone Hip Tool	Orthopedic Sciences, Inc.	2007	1
K040850	Tsy Shoulder Plate Implant	Orthopedic Sciences, Inc.	2004	1
K052538	S-Bone Hip Tool	Orthopedic Sciences, Inc.	2005	0
K051032	Titanium-Hip Tool	Orthopedic Sciences, Inc.	2005	0
K051181	Custom-Hip Tool	Orthopedic Sciences, Inc.	2005	0

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 17 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
6 of the 41 ancestors have a recall of any class.
Of its descendants, K063709 (Orthopedic Sciences, Inc., 2007) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K982222.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)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 Hip Tool™ Implant is intended to stabilize a bone graft within the femoral head and neck to

assist healing of an intraosseous fracture.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022139 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022139: Hip Tool Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022139

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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